Clinical trial NCT00776841: A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase-I
Hypercholesterolemia
Obesity
fatty liver
Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers
Lead sponsor: Galmed Medical Reserch
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 41
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: day 1 to 6
Secondary outcomes:
measure: To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.
timeFrame: day 1 to 6
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tasmc Clinical Research Center
Study officials:
affiliation: TASMC CLINICAL RESEARCH CENTER
name: Jacob Atsmon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: