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

NCT ID: NCT00776841

Last Updated: 2010-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-10-31

Brief Summary

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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

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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

Conditions

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Healthy

Keywords

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Phase-I Hypercholesterolemia Obesity fatty liver Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo control single dose

Group Type PLACEBO_COMPARATOR

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

Oral Aramchol at dose 30 mg to 900 mg

Aramchol

Intervention Type DRUG

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

Dose 1

Dose 30 mg

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

Oral Aramchol at dose 30 mg to 900 mg

Aramchol

Intervention Type DRUG

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

Dose 2

Dose 100 mg

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

Oral Aramchol at dose 30 mg to 900 mg

Aramchol

Intervention Type DRUG

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

Dose 3

Dose 300 mg

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

Oral Aramchol at dose 30 mg to 900 mg

Aramchol

Intervention Type DRUG

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

Dose 4

Dose 900 mg

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

Oral Aramchol at dose 30 mg to 900 mg

Aramchol

Intervention Type DRUG

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

Dose 1 repeated

Dose 30 mg for 4 days

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

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

Dose 2 repeated

Dose high for 4 days

Group Type EXPERIMENTAL

Aramchol

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Aramchol

Oral Aramchol at dose 30 mg to 900 mg

Intervention Type DRUG

Aramchol

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Galmed Medical Reserch

INDUSTRY

Sponsor Role lead

Responsible Party

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Galmed Medical Research

Principal Investigators

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Jacob Atsmon, M.D.

Role: PRINCIPAL_INVESTIGATOR

TASMC CLINICAL RESEARCH CENTER

Locations

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Tasmc Clinical Research Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PROTOCOL No: TRC 037/10072

Identifier Type: -

Identifier Source: org_study_id