drugset / Trial / NCT00776841
A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
RandomizedSingle-groupQuadruple-blindTreatment
Summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers. Primary Objectives: 1. To assess and characterize the safety and tolerability of Aramchol in 16 healthy male subjects at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses (Part B) 2. To assess the pharmacokinetics of Aramchol at the administered doses
Timeline
- Start
- 2008-09
- Primary completion
- 2009-09
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aramchol | Other / unclassified | 30 mg | Oral |
| Subject | Aramchol | Other / unclassified | 100 mg | Oral |
| Subject | Aramchol | Other / unclassified | 300 mg | Oral |
| Subject | Aramchol | Other / unclassified | 900 mg | Oral |
Indications
No indication recorded.