drugset / Trial / NCT02803996
Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers
Phase 1
Completed
64 enrolled
Galmed Pharmaceuticals Ltd
Alpha IRB · collabAnalyst Research Laboratories · collabDiamond Pharma Services Regulatory Affairs Consultancy · collabKramer Consulting, LLC · collabWCCT Global · collab
RandomizedParallel-groupQuadruple-blind
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.
Timeline
- Start
- 2016-05
- Primary completion
- 2016-09
- Completion
- 2016-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aramchol | Other / unclassified | 400 mg | Oral |
| Comparator | Aramchol | Other / unclassified | 600 mg | Oral |
Indications
No indication recorded.