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

NCT00776841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2010-11-03

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Galmed Medical Reserch

    lead INDUSTRY

Principal Investigators

  • Jacob Atsmon, M.D. · TASMC CLINICAL RESEARCH CENTER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-09-30
Completion
2009-10-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00776841 on ClinicalTrials.gov