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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
Sponsor:
Information provided by:
Galmed Medical Reserch

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: Aramchol Phase 1

Detailed 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<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 Design
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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

Resource links provided by the National Library of Medicine


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

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

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Israel
Tasmc Clinical Research Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Galmed Medical Reserch
Investigators
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Principal Investigator: Jacob Atsmon, M.D. TASMC CLINICAL RESEARCH CENTER
More Information
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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
Keywords provided by Galmed Medical Reserch:
Phase-I
Hypercholesterolemia
Obesity
fatty liver
Part A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers
Additional relevant MeSH terms:
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Cholic Acids
Bile Acids and Salts
Gastrointestinal Agents