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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06089837




Registration number
NCT06089837
Ethics application status
Date submitted
12/10/2023
Date registered
18/10/2023

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Oral EC5026 in Healthy Subjects
Scientific title
A Phase 1b Multiple Ascending Dose (MAD) Study of EC5026 in Healthy Volunteers
Secondary ID [1] 0 0
EC5026-1-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EC5026 oral tablet
Treatment: Drugs - Placebo oral tablet

Experimental: EC5026 - Multiple Ascending Doses of oral EC5026

Experimental: Placebo - Single doses of matching oral placebo


Treatment: Drugs: EC5026 oral tablet
2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days.

Oral doses of EC5026 tested in each cohort:

4 mg loading dose on Day 1 / 2 mg Maintenance dose on Days 2-7 (Cohort 1) 8 mg loading dose on Day 1 / 4 mg Maintenance dose on Days 2-7 (Cohort 2)

Treatment: Drugs: Placebo oral tablet
2 sequential cohorts of 8 subjects randomly assigned to receive multiple ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort) for 7 consecutive days. Subject assigned to the Placebo Arm will receive 7 days of matching placebo oral tablets in each Cohort.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAE) [Safety and Tolerability]
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Dose-related effects on electrocardiographic QTc interval (concentration QTc analysis)
Timepoint [2] 0 0
7 days
Primary outcome [3] 0 0
Changes-from-baseline in electrocardiographic time intervals
Timepoint [3] 0 0
7 days
Primary outcome [4] 0 0
Area under the plasma concentration versus time curve (AUC) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [4] 0 0
30 days
Primary outcome [5] 0 0
Maximum observed plasma concentration (Cmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [5] 0 0
30 days
Primary outcome [6] 0 0
Time to maximum observed plasma concentration (Tmax) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [6] 0 0
30 days
Primary outcome [7] 0 0
Terminal elimination rate constant in plasma (Kel) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [7] 0 0
30 days
Primary outcome [8] 0 0
Terminal phase half-life in plasma (t1/2) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [8] 0 0
30 days
Primary outcome [9] 0 0
Apparent total body clearance (CL/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [9] 0 0
30 days
Primary outcome [10] 0 0
Apparent volume of distribution based on the terminal elimination rate constant in plasma (Vz/F) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [10] 0 0
30 days
Primary outcome [11] 0 0
Renal clearance (CLR) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [11] 0 0
7 days
Primary outcome [12] 0 0
Amount of drug excreted unchanged in urine (Ae) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [12] 0 0
7 days
Primary outcome [13] 0 0
Fraction of eliminated dose in urine (Fe%) in response to 2 multiple ascending dose regimens of EC5026 oral tablets [Plasma Pharmacokinetics].
Timepoint [13] 0 0
7 days

Eligibility
Key inclusion criteria
Each subject must meet all of the following criteria to be enrolled in this study:

1. Male and female subjects must be 18 years or older.
2. Subjects must be willing to provide written informed consent to participate in the study.
3. Subjects must be in generally good health as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements.
4. Subjects must be willing to remain in confinement at the clinical study unit for up to 8.5 consecutive days and to return to the unit as specified for additional blood tests and safety evaluations during the study period.
5. Subjects must have a body mass index (BMI) of 19-32 kg/m2. Participants with a BMI below 19 kg/m2 may be enrolled at the Investigator's discretion.
6. Subjects must have a systolic blood pressure (BP) of 90-160 mmHg, diastolic BP of 50-90 mmHg, and resting HR of 40-100 beats per min without medication at Screening.
7. Subjects must have clinical chemistry values for electrolytes, alkaline phosphatase (ALP), alanine aminotransferase (ALT <1.5x ULN), aspartate aminotransferase (AST, <1.5x ULN), lactate dehydrogenase (LDH), creatine phosphokinase (CPK), creatinine, bilirubin (<2x ULN), and urea that are within the normal range without medication or not clinically significant for a healthy population in the opinion of the Investigator at Screening. Renal clearance measured by eGFR must be normal (=80 mL/min). Urinalysis values must be within normal limits or not clinically significant for a healthy population in the opinion of the Investigator at Screening. Laboratory analyses and urinalysis may be repeated once at the Investigator's discretion to confirm the accuracy of the results.
8. Subjects must have an early morning (drawn seated between 0600 am and 0800 am) serum cortisol level >5 mcg/dL (>137.9 nmol/L) and early morning adrenocorticotropic hormone (ACTH) and aldosterone levels within the normal range at screening. Randomization will be conditional to a normal cortisol response to ACTH stimulation during screening [serum cortisol level =16 mcg/dL (=440 nmol/L) after IM ACTH injection].
9. Subjects must be non-smokers or previous smokers who have not smoked within the previous 6 months prior to Screening.
10. Male participants must use, from randomization until at least 2 months after the last dose, a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), e.g.: sterilisation (e.g., vasectomy), and/or barrier forms of contraception, including condoms (external or internal) and diaphragm ('cap').
11. Male subjects must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
12. Female subjects must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or they must agree to use a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 2 months after clinic discharge. Highly effective contraception methods include: Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g., Mirena®), and/or barrier methods of contraception, including condoms (external or internal) and diaphragm ('cap'). Hormonal methods of contraception (with the exception of hormonal IUD) are not permitted within this study. Female participants will refrain from using hormonal contraceptives for at least 28 days prior to study entry until the end of the study period. Participants/Participant's partner(s) must also use a barrier form of contraception, from the first dose of study drug through until 2 months after the last dose. For all females of childbearing potential, the pregnancy test result must be negative at Screening and Pre-Study Baseline (Day -1).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects meeting any of the following criteria will be excluded from the study:

1. Subjects who have used any non-study medication(s), including low-dose aspirin for cardiovascular prophylaxis, within 1 week before administration of study drug.
2. Subjects who have used chemotherapy agents, or who have a personal history of cancer or metastatic cancer in first degree relatives suggestive of elevated cancer risk in the opinion of the investigator, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to Screening.
3. Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
4. Subjects with a presence or history of peripheral edema within the past 5 years, with the exception of that caused by trauma.
5. Subjects with a history of disorders of the HPA or HPG axis.
6. Subjects with a history of congestive heart failure.
7. Subjects who have used (within 30 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are cytochrome P450 (CYP450) inducers or inhibitors (e.g., cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, or clarithromycin).
8. Subjects who have used (within 30 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are known to modulate drug metabolizing enzymes (e.g., St. John's wort, grapefruit juice).
9. Subjects with difficulty in swallowing oral medications.
10. Subjects with serious psychosocial comorbidities as determined by the Investigator.
11. Subjects with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures and/or confinement in a clinical study unit for up to 8.5 days.
12. Subjects with a positive drug or alcohol test during Screening and/or admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator).
13. Subjects who have used any other investigational drug within 1 month prior to Screening.
14. Subjects who have used any over-the-counter medications within 2 weeks of randomization, or paracetamol or ibuprofen within 7 days of randomization
15. Subjects who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to randomization.
16. Subjects with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment.
17. Subjects with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).
18. Subjects with a cumulative exposure to any oral or inhaled glucocorticoid of more than 1 week duration within 6 months prior to randomization.
19. Subjects with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID-19) at the time of Screening.
20. Subjects with confirmed moderate-severe COVID-19 within 2 months of randomization or with confirmed asymptomatic or mild COVID-19 within 4 weeks of randomization.
21. Subjects who have received a COVID-19 vaccine within 4 weeks of randomization or are planning on receiving it during the study duration.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EicOsis Human Health Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cory D Sellwood, MBChB
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cory D Sellwood, MBChB
Address 0 0
Country 0 0
Phone 0 0
0800862278
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT06089837