NCT00776841

A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Galmed Medical Reserch · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

Number of Subjects: Total: A total of 46 healthy subjects will be enrolled. Part A: Sixteen (16) subjects will participate in four, 8-person dosing periods. Each cohort will be alternately dosed twice. Part B: Thirty (30) subjects will be enrolled in two, 15-person dose-ascending cohorts. Main Inclusion Criteria: Part A: Healthy male volunteers aged 18-50 (inclusive) years who have provided written informed consent Part B: Mildly overweight (25\<BMI\<33), with fasting cholesterol levels of 200-300 mg/% or LDL 100-180 mg/% and triglycerides \< 200 mg/%, otherwise healthy male volunteers aged 18-50 (inclusive) years, who have provided written informed consent

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Aramchol	1.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)
DRUG	Aramchol	Oral Aramchol at dose 30 mg to 900 mg
DRUG	Aramchol	Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2008-10-21
• Last updated: 2010-11-03

Locations

1 site across 1 country: Israel