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Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered Under Fed Conditions in Healthy Chinese Volunteers

NCT02803996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2016-12-21

No results posted yet for this study

Summary

This is a single-site, randomized, double-blind, double dummy, placebo-controlled single and multiple doses study of Aramchol in healthy Chinese volunteers. The subject population that was enrolled for Aramchol 004 was not specifically designed to understand the PK profile of Aramchol in subjects of Chinese descent. Therefore, this study (Aramchol 015) has been undertaken to ascertain the PK profile of Aramchol following single and multiple doses in a Chinese population under fed conditions utilizing the light breakfast from Aramchol 004.

This study will consist of two parts and the subjects will be assigned to two parts.

In each part of the study, subjects will be enrolled in the study within 28 days of screening.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Aramchol

Part A: Aramchol oral tablets at 400 mg or 600 mg single dose Part B: Aramchol oral tablets at 400 mg or 600 mg multiple dose for 10 consecutive days.

DRUG

Placebo

Part A: Placebo oral tablets single dose Part B: Placebo oral tablets multiple dose for 10 consecutive days.

Sponsors & Collaborators

  • WCCT Global

    collaborator INDUSTRY

  • Alpha IRB

    collaborator UNKNOWN

  • Analyst Research Laboratories

    collaborator OTHER

  • Kramer Consulting, LLC

    collaborator OTHER

  • Diamond Pharma Services Regulatory Affairs Consultancy

    collaborator OTHER

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02803996 on ClinicalTrials.gov