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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
41
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)
Oral Aramchol at dose 30 mg to 900 mg
Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days
Tasmc Clinical Research Center
Tel Aviv, Israel
To assess safety and tolerability and Pharmacokinetics of Aramchol at single doses ranging between 30 and 900 mg (Part A) and in 30 overweight, mildly hypercholesterolemic, subjects receiving multiple doses (Part B)
Time frame: day 1 to 6
To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.
Time frame: day 1 to 6
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