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

Galmed Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aramchol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776841

PROTOCOL No: TRC 037/10072

Details and patient eligibility

About

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

Full 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

Enrollment: 41 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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41 participants in 7 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo control single dose

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 1

Experimental group

Description:

Dose 30 mg

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 2

Experimental group

Description:

Dose 100 mg

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 3

Experimental group

Description:

Dose 300 mg

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 4

Experimental group

Description:

Dose 900 mg

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 1 repeated

Experimental group

Description:

Dose 30 mg for 4 days

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol

Dose 2 repeated

Experimental group

Description:

Dose high for 4 days

Treatment:

Drug: Aramchol

Drug: Aramchol

Drug: Aramchol