NCT00776841

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. 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. 2.To assess the pharmacokinetics of Aramchol at the administered doses

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 3, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

October 19, 2008

Last Update Submit

November 2, 2010

Conditions

Healthy

Keywords

Phase-IHypercholesterolemiaObesityfatty liverPart A: Healthy male volunteers Part B: Mildly overweight, otherwise healthy hypercholesterolemic male volunteers

Outcome Measures

Primary Outcomes (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)

    day 1 to 6

Secondary Outcomes (1)

  • To assess and characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.

    day 1 to 6

Study Arms (7)

Placebo

PLACEBO COMPARATOR

Placebo control single dose

Drug: Aramchol

Dose 1

EXPERIMENTAL

Dose 30 mg

Drug: Aramchol

Dose 2

EXPERIMENTAL

Dose 100 mg

Drug: Aramchol

Dose 3

EXPERIMENTAL

Dose 300 mg

Drug: Aramchol

Dose 4

EXPERIMENTAL

Dose 900 mg

Drug: Aramchol

Dose 1 repeated

EXPERIMENTAL

Dose 30 mg for 4 days

Drug: Aramchol

Dose 2 repeated

EXPERIMENTAL

Dose high for 4 days

Drug: Aramchol

Interventions

AramcholDRUG

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)

Also known as: 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate
Dose 1Dose 1 repeatedDose 2Dose 2 repeatedDose 3Dose 4Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tasmc Clinical Research Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

HypercholesterolemiaObesityFatty Liver

Interventions

aramchol

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Jacob Atsmon, M.D.

    TASMC CLINICAL RESEARCH CENTER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2008

First Posted

October 21, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2009

Study Completion

October 1, 2009

Last Updated

November 3, 2010

Record last verified: 2010-11

Locations

IL(1)