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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776841
• Other study ID #: PROTOCOL No: TRC 037/10072
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2008
• Last updated: November 2, 2010
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2010
• Source: Galmed Medical Reserch
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Israel	Tasmc Clinical Research Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Galmed Medical Reserch

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		day 1 to 6	Yes
Secondary	To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.		day 1 to 6	Yes