A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Aramchol
- Conditions
- Healthy
- Sponsor
- Galmed Medical Reserch
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers.
Primary Objectives:
- 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)
- 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
Investigators
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
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.
Arms & Interventions
Placebo
Placebo control single dose
Intervention: Aramchol
Dose 1
Dose 30 mg
Intervention: Aramchol
Dose 2
Dose 100 mg
Intervention: Aramchol
Dose 3
Dose 300 mg
Intervention: Aramchol
Dose 4
Dose 900 mg
Intervention: Aramchol
Dose 1 repeated
Dose 30 mg for 4 days
Intervention: Aramchol
Dose 2 repeated
Dose high for 4 days
Intervention: Aramchol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.(day 1 to 6)