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Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers

NCT02374437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2015-02-27

No results posted yet for this study

Summary

This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol in sixty six (66) healthy male volunteers.

In each part of the study subjects will be enrolled in the study within 28 days before drug administration(s).

The study will consist of three parts and the subjects will be assigned to three Parts.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Aramchol

PART A: Subjects will receive single dose of 200 or 400 mg Aramchol PART B: Subjects will receive single dose of 600 mg Aramchol under fasting or fed conditions ( following a crossover between the groups) PART C: subjects will be equally randomized to receive either 200 mg, 400 mg, 600 mg or placebo tablets for ten consecutive days.

DRUG

Placebo

PART C: subjects will be equally randomized to receive either 200 mg, 400 mg, 600 mg or placebo tablets for ten consecutive days.

Sponsors & Collaborators

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Maya Halpern, MD · GALMED PHARMCEUTICALS

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02374437 on ClinicalTrials.gov