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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Aramchol

• Registration Number: NCT00776841
• Lead Sponsor: Galmed Medical Reserch

Brief 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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-19
• Study First Submitted QC: 2008-10-20
• Study First Posted: 2008-10-21
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-02
• Last Update Posted: 2010-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

Major

Exclusion Criteria

• History of significant neurological (including history of seizures or EEG abnormalities), renal, cardiovascular (including known structural cardiac abnormalities or hypertension), respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm, psychological (marked anxiety, tension or agitation) or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
• History of drug or alcohol abuse.
• Known allergy to any drug. Known allergy to any drug.
• Clinically significant abnormalities found in the screening physical exam.
• Significant abnormalities in clinical laboratory parameters (hematology, biochemistry, urinalysis) determined within 40 days of the start of the study and on Day (-1) before first dosing session. Parameters to be measured are those shown in Appendix 2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose 4	Aramchol	Dose 900 mg
Dose 1 repeated	Aramchol	Dose 30 mg for 4 days
Dose 2 repeated	Aramchol	Dose high for 4 days
Dose 3	Aramchol	Dose 300 mg
Dose 1	Aramchol	Dose 30 mg
Placebo	Aramchol	Placebo control single dose
Dose 2	Aramchol	Dose 100 mg

Primary Outcome Measures

Name	Time	Method
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)	day 1 to 6

Secondary Outcome Measures

Name	Time	Method
To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.	day 1 to 6

Trial Locations

Locations (1)

Tasmc Clinical Research Center; 🇮🇱 Tel-Aviv, Israel