Trial | NCT00776841  Report issue

Title

A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    aramchol ...

  • Study Participants

    41
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
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
Study Started
Sep 30
2008
Primary Completion
Sep 30
2009
Study Completion
Oct 31
2009
Last Update
Nov 03
2010
Estimate

Drug Aramchol

1.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)

  • Other names: 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate

Drug Aramchol

Oral Aramchol at dose 30 mg to 900 mg

Drug Aramchol

Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days

Placebo Placebo Comparator

Placebo control single dose

Dose 1 Experimental

Dose 30 mg

Dose 2 Experimental

Dose 100 mg

Dose 3 Experimental

Dose 300 mg

Dose 4 Experimental

Dose 900 mg

Dose 1 repeated Experimental

Dose 30 mg for 4 days

Dose 2 repeated Experimental

Dose high for 4 days

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.
No Results Posted