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Lipid Modifying Agent
Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers
Phase 1
Waitlist Available
Research Sponsored by Galmed Pharmaceuticals Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a:pre-dose (within 60 min before dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18, 24, 30, 36, 48(±60 min), 72 (±60 min), 96 (±60 min), 144 (±60 min) hours post-dose. part b:dosing days 1-10
Summary
This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004. This study will consist of two parts and the subjects will be assigned to two parts. In each part of the study, subjects will be enrolled in the study within 28 days of screening.
Eligible Conditions
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part b: dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part b: dosing days 1 and 2: pre-dose (within 60 min before first dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 18 and 24 (before second dosing) hours after drug administration+ day 3-10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Adverse Event (AE) Profile
Clinical Laboratory Safety Tests
Trial Design
6Treatment groups
Active Control
Placebo Group
Group I: Part A- Single Dose- 400 mg AramcholActive Control1 Intervention
Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo.
Group II: Part A- Single Dose- 600 mg AramcholActive Control1 Intervention
Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo.
Group III: Part B-Multiple Dose-400 mg AramcholActive Control1 Intervention
Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days.
Group IV: Part B-Multiple Dose-600 mg AramcholActive Control1 Intervention
Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days.
Group V: Part A-Single Dose-PlaceboPlacebo Group1 Intervention
Part A: Subjects will receive a single dose of 400 mg Aramchol, 600 mg Aramchol or placebo.
Group VI: Part B-Multiple Dose-PlaceboPlacebo Group1 Intervention
Part B: Subjects will receive multiple doses of 400 mg Aramchol, 600 mg Aramchol or placebo tablets for 10 consecutive days.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Galmed Pharmaceuticals LtdLead Sponsor
8 Previous Clinical Trials
208 Total Patients Enrolled
WCCT GlobalIndustry Sponsor
13 Previous Clinical Trials
839 Total Patients Enrolled
Alpha IRBUNKNOWN
Analyst Research LaboratoriesOTHER
2 Previous Clinical Trials
31 Total Patients Enrolled
Kramer Consulting, LLCOTHER
2 Previous Clinical Trials
25 Total Patients Enrolled
Diamond Pharma Services Regulatory Affairs ConsultancyOTHER
4 Previous Clinical Trials
308 Total Patients Enrolled