Status:
COMPLETED
A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Lead Sponsor:
Galmed Medical Reserch
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
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 safet...
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 twic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00776841
Start Date
September 1 2008
End Date
October 1 2009
Last Update
November 3 2010
Active Locations (1)
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1
Tasmc Clinical Research Center
Tel Aviv, Israel, 64239