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Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers

NCT03760848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-08-22

No results posted yet for this study

Summary

The trial is an open-label, 2-period, single-sequence assessment of CYP3A4 inhibition by aramchol using the probe substrates midazolam and atorvastatin to assess CYP3A4 activity.

Conditions

  • Healthy

Interventions

DRUG

Aramchol

Aramchol 600 mg

DRUG

Midazolam

Midazolam 2 mg

DRUG

Atorvastatin

atorvastatin 40 mg

Sponsors & Collaborators

  • Hammersmith Medicines Research

    collaborator OTHER

  • Analyst Research Laboratories

    collaborator OTHER

  • Alderley Analytical Ltd.

    collaborator INDUSTRY

  • Diamond Pharma Services Regulatory Affairs Consultancy

    collaborator OTHER

  • Galmed Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Adeep Puri, M.D. · HMR

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2019-02-02
Completion
2019-02-02

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT03760848 on ClinicalTrials.gov