A Phase 1 Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers
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ClinicalTrials.gov Identifier: NCT00776841 |
Recruitment Status :
Completed
First Posted : October 21, 2008
Last Update Posted : November 3, 2010
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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:
- 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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Aramchol | Phase 1 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single and Multiple-Dose Study of Aramchol in Healthy Male Volunteers |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo control single dose
|
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:
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 |
Experimental: Dose 1
Dose 30 mg
|
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:
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 |
Experimental: Dose 2
Dose 100 mg
|
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:
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 |
Experimental: Dose 3
Dose 300 mg
|
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:
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 |
Experimental: Dose 4
Dose 900 mg
|
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:
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 |
Experimental: Dose 1 repeated
Dose 30 mg for 4 days
|
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:
Drug: Aramchol Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days |
Experimental: Dose 2 repeated
Dose high for 4 days
|
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:
Drug: Aramchol Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days |
- 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 ]
- To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations. [ Time Frame: day 1 to 6 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776841
Israel | |
Tasmc Clinical Research Center | |
Tel-Aviv, Israel, 64239 |
Principal Investigator: | Jacob Atsmon, M.D. | TASMC CLINICAL RESEARCH CENTER |
Responsible Party: | Dr. Itzchak Angel, Vice President, Research & Development, Galmed Medical Research |
ClinicalTrials.gov Identifier: | NCT00776841 |
Other Study ID Numbers: |
PROTOCOL No: TRC 037/10072 |
First Posted: | October 21, 2008 Key Record Dates |
Last Update Posted: | November 3, 2010 |
Last Verified: | November 2010 |
Phase-I Hypercholesterolemia Obesity fatty liver Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers |
Cholic Acids Bile Acids and Salts Gastrointestinal Agents |