A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
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