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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05363839
Registration number
NCT05363839
Ethics application status
Date submitted
1/03/2022
Date registered
6/05/2022
Titles & IDs
Public title
To Assess the Safety, Tolerability and Pharmacokinetics of ACH-000029 in Healthy Subjects
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Scientific title
A Phase 1, Single-center, Placebo-controlled, Double-blind, Randomized Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of ACH-000029 in Healthy Subjects
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Secondary ID [1]
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X07-201-00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ACH-000029
Treatment: Drugs - Placebo
Experimental: SAD Cohorts 1 to 3 - Participants Receiving ACH-000029 - Each SAD cohort participant will be randomized to receive 10mg for cohort 1; up to 30mg and up to 60mg for cohorts 2 and 3 respectively dependent on dose review committee.
Placebo comparator: SAD Cohorts 1 to 3 - Participants Receiving Placebo - Each SAD cohort participant will be randomized to receive placebo on a ratio of 3:1 (active: placebo).
Treatment: Drugs: ACH-000029
ACH-000029 will be administered orally via a capsule.
Treatment: Drugs: Placebo
Placebo will be administered orally via a capsule.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number (%) of subjects experiencing orthostatic hypotension at any timepoint
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Assessment method [1]
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Orthostatic assessment will be with the criteria = 20 mmHg decrease in SBP and a \> 25 bpm increase in HR from supine to standing.
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Timepoint [1]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [2]
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Maximum change in timepoint-matched systolic blood pressure and diastolic blood pressure.
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Assessment method [2]
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Timepoint [2]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [3]
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Maximum change in timepoint-matched resting heart rate.
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Assessment method [3]
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Timepoint [3]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [4]
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Assessment of abnormal clinical laboratory tests (Hemoglobin & mean corpuscular hemoglobin concentration)
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Assessment method [4]
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Timepoint [4]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [5]
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Assessment of abnormal clinical laboratory tests (Hematocrit)
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Assessment method [5]
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Timepoint [5]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [6]
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Assessment of abnormal clinical laboratory tests (Mean corpuscular volume)
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Assessment method [6]
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Timepoint [6]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [7]
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Assessment of abnormal clinical laboratory tests (RBC count)
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Assessment method [7]
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Timepoint [7]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [8]
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Assessment of abnormal clinical laboratory tests (WBC count (absolute and differential))
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Assessment method [8]
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Timepoint [8]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [9]
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Assessment of abnormal clinical laboratory tests (Platelets)
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Assessment method [9]
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Timepoint [9]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [10]
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Assessment of abnormal clinical laboratory tests (Mean platelet volume)
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Assessment method [10]
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Timepoint [10]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [11]
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Assessment of abnormal clinical laboratory tests (Anion gap, bicarbonate, calcium, chloride, cholesterol, glucose, magnesium, potassium, sodium, creatinine, uric acid, triglycerides, urea)
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Assessment method [11]
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Timepoint [11]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [12]
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Assessment of abnormal clinical laboratory tests (Lactate Dehydrogenase (LDH), Alanine Transaminase (ALT), gamma-glutamyl transferase (GGT), Alkaline phosphatase (ALP) , aspartate aminotransferase (AST), phosphatase, creatinine phosphokinase)
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Assessment method [12]
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Timepoint [12]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [13]
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Assessment of abnormal clinical laboratory tests (Albumin)
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Assessment method [13]
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Timepoint [13]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [14]
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Assessment of abnormal clinical laboratory tests (Glomerular filtration rate)
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Assessment method [14]
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Timepoint [14]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [15]
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Assessment of abnormal clinical laboratory tests (Globulin)
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Assessment method [15]
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Timepoint [15]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [16]
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Assessment of abnormal clinical laboratory tests (Total bilirubin)
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Assessment method [16]
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Timepoint [16]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [17]
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Assessment of abnormal clinical laboratory tests (Total protein)
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Assessment method [17]
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Timepoint [17]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [18]
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Coagulation
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Assessment method [18]
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Blood sample assessments will include activated partial thromboplastin time, prothrombin time-international normalized ratio.
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Timepoint [18]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [19]
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Assessment of abnormal Urinalysis (Bilirubin, blood, glucose, ketones, nitrites, protein)
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Assessment method [19]
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Timepoint [19]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [20]
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Assessment of abnormal Urinalysis (Leukocyte esterase)
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Assessment method [20]
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Timepoint [20]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [21]
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Assessment of abnormal Urinalysis (Microscopic analysis)
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Assessment method [21]
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0
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Timepoint [21]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [22]
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Assessment of abnormal Urinalysis (pH)
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Assessment method [22]
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0
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Timepoint [22]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [23]
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Assessment of abnormal Urinalysis (Specific gravity)
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Assessment method [23]
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0
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Timepoint [23]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [24]
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Assessment of abnormal Vital signs (temperature)
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Assessment method [24]
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Temperature will be assessed after subject has been in supine position for at least 3 minutes.
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Timepoint [24]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [25]
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Assessment of abnormal Vital signs (respiratory rate)
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Assessment method [25]
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Respiratory rate will be assessed after subject has been in supine position for at least 3 minutes.
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Timepoint [25]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [26]
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Assessment of abnormal Vital signs (blood pressure)
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Assessment method [26]
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Blood pressure will be assessed in supine and standing positions in each position for at least 3 minutes.
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Timepoint [26]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [27]
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Assessment of abnormal Vital signs (heart rate)
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Assessment method [27]
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Heart rate will be assessed in supine and standing positions in each position for at least 3 minutes.
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Timepoint [27]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [28]
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Assessment of Physical examinations (height)
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Assessment method [28]
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Timepoint [28]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [29]
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Assessment of Physical examinations (weight)
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Assessment method [29]
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Timepoint [29]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [30]
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Assessment of Physical examinations (BMI)
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Assessment method [30]
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Timepoint [30]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [31]
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Assessment of Physical examinations
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Assessment method [31]
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Subjects will be visually assessed for any abnormalities with head, eyes, ears, nose and throat; thorax; abdomen; urogenital; skin and mucosae.
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Timepoint [31]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [32]
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Assessment of Neurological examinations
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Assessment method [32]
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Subjects will be assessed for any abnormalities and evaluated for mental status, cranial nerves, motor system, reflexes, sensory system, coordination and station and gait.
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Timepoint [32]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [33]
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12-lead ECG assessment of PR interval
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Assessment method [33]
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Change in electrocardiograms
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Timepoint [33]
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Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
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Primary outcome [34]
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12-lead ECG assessment of QRS duration
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Assessment method [34]
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Change in electrocardiograms
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Timepoint [34]
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Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
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Primary outcome [35]
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12-lead ECG assessment of QT interval
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Assessment method [35]
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Change in electrocardiograms
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Timepoint [35]
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Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
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Primary outcome [36]
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12-lead ECG assessment of QTc
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Assessment method [36]
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Change in electrocardiograms
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Timepoint [36]
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Screening (Days -28 to Day -2), Day -1, Day 1, Day 2, Day 4 and end of treatment Day 7
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Primary outcome [37]
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C-SSRS
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Assessment method [37]
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Subjects will be interviewed to capture the occurrence, severity and frequency of suicide-related thoughts and behaviors.
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Timepoint [37]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [38]
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Monitoring of adverse events
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Assessment method [38]
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Any untoward medical occurrence in a subject, whether considered related to the treatment or not.
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Timepoint [38]
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Screening (Days -28 to Day -2) to end of treatment Day 7
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Primary outcome [39]
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Pharmacokinetic assessment 1
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Assessment method [39]
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Peak Plasma Concentration (Cmax)
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Timepoint [39]
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Day 1 to end of treatment Day 7
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Primary outcome [40]
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Pharmacokinetic assessment 2
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Assessment method [40]
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Time of peak plasma concentration (Tmax)
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Timepoint [40]
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Day 1 to end of treatment Day 7
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Primary outcome [41]
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Pharmacokinetic assessment 3
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Assessment method [41]
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Area under the concentration-time curve calculated to the last observable concentration at time (AUCt)
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Timepoint [41]
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Day 1 to end of treatment Day 7
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Primary outcome [42]
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Pharmacokinetic assessment 4
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Assessment method [42]
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Area under the concentration-time curve from zero to infinity (AUC8)
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Timepoint [42]
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Day 1 to end of treatment Day 7
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Primary outcome [43]
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Pharmacokinetic assessment 5
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Assessment method [43]
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Apparent clearance of the drug normalized to body weight (CL/F)
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Timepoint [43]
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Day 1 to end of treatment Day 7
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Primary outcome [44]
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Pharmacokinetic assessment 6
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Assessment method [44]
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Apparent clearance of the drug normalized to body weight (CL/F)
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Timepoint [44]
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Day 1 to end of treatment Day 7
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Primary outcome [45]
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Pharmacokinetic assessment 7
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Assessment method [45]
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Terminal-phase elimination half-life (t1/2,z)
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Timepoint [45]
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Day 1 to end of treatment Day 7
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Primary outcome [46]
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Pharmacokinetic assessment 8
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Assessment method [46]
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Cmax normalized to dose (Cmax/Dose)
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Timepoint [46]
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Day 1 to end of treatment Day 7
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Primary outcome [47]
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Pharmacokinetic assessment 9
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Assessment method [47]
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Cmax normalized to dose (Cmax/Dose)
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Timepoint [47]
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Day 1 to end of treatment Day 7
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Primary outcome [48]
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Pharmacokinetic assessment 10
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Assessment method [48]
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AUCt normalized to dose (AUCt/Dose)
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Timepoint [48]
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Day 1 to end of treatment Day 7
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Primary outcome [49]
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Pharmacokinetic assessment 11
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Assessment method [49]
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AUC8 normalized to dose (AUC8/Dose)
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Timepoint [49]
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Day 1 to end of treatment Day 7
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Eligibility
Key inclusion criteria
* Healthy male or non-childbearing potential female.
* Surgically sterile male and female.
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Breastfeeding female subjects.
* Clinical abnormal past medical history.
* History of drug and/or alcohol abuse within 2 years prior to screening.
* History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen and/or anti-hepatitis C virus antibodies, or human immunodeficiency virus (HIV) antibodies.
* History of any significant drug allergy or known or suspected hypersensitivity.
* A positive urine or breath alcohol test and/or urine drug screen for substances of abuse at screening or upon admission to the trial site (Day -1).
* Subjects having taken an investigational drug within 30 days prior to screening or a biological investigational product within 30 days or 5 half-lives (whichever is longer) preceding screening, except the last dose of severe acute respiratory syndrome coronavirus (SARS-CoV-2 [COVID-19]) vaccine, which must be administered at least 7 days prior to screening.
* Any history of significant bleeding or hemorrhagic tendencies.
* Any history of difficulty in donating blood.
* The donation of blood or plasma within 30 days prior to the first dose of IMP.
* Use of prescription, over-the-counter, or herbal medications or vitamin supplements within 14 days prior to the first dose of IMP and oral antibiotics within 30 days prior to the first dose of IMP.
* Use of tobacco products or daily exposure to second-hand smoke within 2 months prior to the screening visit.
* Presenting with, or having a history of, uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg) or symptomatic hypotension, or orthostatic hypotension, which is defined as a decrease of = 30 mmHg in SBP or a decrease of = 20 mmHg in DBP after at least 3 minutes of standing compared with the previous supine BP, OR development of symptoms.
* Supine HR, after resting for at least 3 minutes, outside the range of 50 to 90 bpm.
* Abnormal ECG findings at screening or check-in.
* History of unexplained syncope, where orthostatic likely event.
* Personal or family history of sudden death or long QT syndrome.
* History of serious mental disorders that, in the opinion of the investigator, would exclude the subject from participating in this trial.
* No permanent place of residence.
* Subjects with active suicidal ideation prior to dosing.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/11/2022
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Sample size
Target
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Nucleus Network Pty Ltd - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Syneos Health
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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0
Otsuka Pharmaceutical Development & Commercialization, Inc.
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Address [1]
0
0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
Randomized single ascending dose placebo controlled treatment of ACH-000029 administered orally via capsule in healthy volunteers.
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Trial website
https://clinicaltrials.gov/study/NCT05363839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05363839