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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:
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\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aramchol | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations. | day 1 to 6 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Atsmon, M.D. | TASMC CLINICAL RESEARCH CENTER | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tasmc Clinical Research Center | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D009765 | Obesity |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C455117 | aramchol |
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Dose high for 4 days |
|
|
| Aramchol | Drug | Oral Aramchol at dose 30 mg to 900 mg |
|
| Aramchol | Drug | Oral Aramchol at doses 30 mg to 900 mg single dose and 30 mg and high dose for 4 days |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |