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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03597971
Registration number
NCT03597971
Ethics application status
Date submitted
3/05/2018
Date registered
24/07/2018
Date last updated
17/12/2019
Titles & IDs
Public title
HMPL004-6599 Phase I Dose-escalating Study
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Scientific title
A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers
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Secondary ID [1]
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2017-599-00AU1
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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:
Ulcerative Colitis
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Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - HMPL004-6599
Treatment: Drugs - Placebo
Experimental: Part A: experimental - Subjects will receive HMPL004-6599 or matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule. Dose levels may be repeated, or reduced if deemed appropriate by the Safety Monitoring Committee (SMC).
Placebo comparator: Part A: placebo - Subjects will receive matching placebo on Day 1. This will be administered under fed conditions with a standard meal, according to the randomization schedule.
Treatment: Drugs: HMPL004-6599
For each cohort, 6 subjects will receive HMPL004-6599
Treatment: Drugs: Placebo
For each cohort, 2 subjects will receive placebo
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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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Incidence of Treatment-Emergent Adverse Events
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Assessment method [1]
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A primary objective of this study is to assess the safety of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers.
The occurrence of Serious Adverse Events and Adverse Events will be evaluated during the study in order to determine this primary objective.
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Timepoint [1]
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Part A: single dose; Part B: 21 days
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Primary outcome [2]
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Incidence of Participants with Abnormal Laboratory Values
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Assessment method [2]
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A further primary objective of this study is to assess the tolerability of a single dose of up to 1800 mg in Part A (evaluated in planned steps of 600, 1200, and 1800 mg HMPL004-6599 under fed conditions of a standard meal), followed by multiple doses of up to 1800mg in Part B (evaluated in planned steps of 200mg TID, 400mg TID, 600mg BID and 600mg TID HMPL004-599 under fed conditions of a standard meal for 14 days ) in healthy male volunteers.
The occurrence of abnormal laboratory values will be reviewed during the study in order to determine this primary objective.
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Timepoint [2]
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Part A: single dose; Part B: 21 days
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Secondary outcome [1]
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Maximum Plasma Concentration [Cmax]
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Assessment method [1]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Cmax determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [1]
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Part A: single dose; Part B: 21 days
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Secondary outcome [2]
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Area Under The Concentration Time Curve Up To The Time 't' [AUC0-t]
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Assessment method [2]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUC0-t determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [2]
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Part A: single dose; Part B: 21 days
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Secondary outcome [3]
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Time of Maximum Plasma Drug Concentration [Tmax]
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Assessment method [3]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Tmax determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [3]
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Part A: single dose; Part B: 21 days
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Secondary outcome [4]
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Area Under The Concentration Time Curve Up To The Last Data Point Above LOQ [AUClast]
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Assessment method [4]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUClast determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [4]
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Part A: single dose; Part B: 21 days
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Secondary outcome [5]
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Apparent Half-Life For Designated Elimination Phases [t1/2]
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Assessment method [5]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the t1/2 determination after single (Part A) and multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [5]
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Part A: single dose; Part B: 21 days
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Secondary outcome [6]
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Area Under The Concentration-Time Curve During Once Dosing Interval [AUCTau or AUC0-_]
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Assessment method [6]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUCTau or AUC0-_determination after multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [6]
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Part B: 21 days
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Secondary outcome [7]
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Minimum Observed Concentration [Cmin]
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Assessment method [7]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the AUCTau or AUC0-_determination after multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [7]
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Part B: 21 days
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Secondary outcome [8]
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Average Concentration [Cavg]
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Assessment method [8]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Cavg determination after multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [8]
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Part B: 21 days
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Secondary outcome [9]
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%_Fluctuation
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Assessment method [9]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the %_Fluctuation determination after multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [9]
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Part B: 21 days
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Secondary outcome [10]
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Accumulation Ratio_obs
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Assessment method [10]
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Plasma concentration of HMPL004-6599 to evaluate protocol specified Pharmacokinetic parameters. Where these PK parameters are derived from plasma concentrations of AND, DDAND, HM5013620, DAND and NAND and include but are not limited to the Accumulation Ratio_obs determination after multiple (Part B) oral doses in healthy male volunteers.
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Timepoint [10]
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Part B: 21 days
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Eligibility
Key inclusion criteria
Subjects must meet all the following for inclusion in the trial:
1. Informed consent must be obtained in writing for all subjects before enrollment into the study.
2. Healthy male subjects aged 18 to 45 years inclusive at the time of screening.
3. Body mass index =19.0 and = 30.0 kg/m2
4. No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems.
5. No clinically significant laboratory values and urinalysis, as determined by the Clinical Investigator.
6. No clinically significant findings in ECG, blood pressure and heart rate, as determined by the Clinical Investigator.
7. Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study and for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 3 months afterwards.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Subjects presenting with any of the following will not be included in the study:
1. Family history of premature Coronary Heart Disease
2. History of immunosuppression or opportunistic infections or receipt of a live virus vaccination within the 3 months prior to screening.
3. Subjects at risk for tuberculosis (TB), specifically subjects with:
1. Clinical or laboratory evidence of active TB
2. History of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type
3. Latent TB which has not been successfully treated
4. History of hypertension requiring treatment.
5. Any condition requiring the regular use of any medication.
6. Exposure to prescription medications within 30 days prior to Day 1.
7. Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose (except for paracetamol).
8. Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study or in the exclusion period of any previous study with investigational drugs.
9. Treatment in the previous 3 months with any drug known to have a well-defined potential for toxicity to a major organ. Once-off medication such as paracetamol or any medication deemed not clinically significant by the principal investigator can be permitted.
10. Current smoker of more than 10 cigarettes or equivalent / day during past 3 months prior to commencing the study and unable to completely stop smoking during the study.
11. Symptoms of a clinically significant illness in the 3 months before the study.
12. Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
13. Chronic constipation or diarrhea, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), Hemorrhoids or anal diseases with regular or recent presence of blood in feces.
14. History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization/enrollment or any food allergy.
15. Blood or plasma donation of no more than 470 ml during the past 30 days (equivalent to the standard blood donation in Australia) before randomization/enrollment and/or more than 50 ml in the 2 weeks prior to screening.
16. Known positive test for human immunodeficiency virus (HIV).
17. Known positive test for hepatitis B or C, unless caused by immunization.
18. Current evidence of drug abuse or history of drug abuse within one year before randomization/enrollment.
19. History of alcohol abuse or active alcoholism with average weekly alcohol intake that exceeds 21 units.
20. Mental condition rendering the subject incapable to understand the nature, scope, and possible consequences of the study.
21. Adults under guardianship and people with restriction of freedom by administrative or legal decisions.
22. Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study.
23. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
24. Known allergy to plants of the Acanthaceae family.
25. Those Subjects who are Vegetarian due to the requirements of the Standard Meal.
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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 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
20/03/2018
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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
19/11/2018
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Linear Clinical Research - Perth
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Recruitment postcode(s) [1]
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- Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Nutrition Science Partners Limited
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Hutchison Medipharma Limited
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Société des Produits Nestlé (SPN)
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the safety and tolerability of single and multiple doses of HMPL004-6599 in healthy male volunteers
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Trial website
https://clinicaltrials.gov/study/NCT03597971
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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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Wu Yan, MD
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Address
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Hutchison Medipharma Limited
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT03597971
Download to PDF