Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

January 25, 2016 updated by: Merck Sharp & Dohme LLC

A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects

The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
  • Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Exclusion Criteria:

  • Is pregnant or breastfeeding
  • Has another clinically significant medical conditions or laboratory abnormality(s)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDX719 + RTV
Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Drug: IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.
Drug: Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
Other Names:
  • Olysio™
Drug: TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.
Drug: RTV
RTV will be supplied as 80 mg/mL solution for oral administration.
Other Names:
  • Norvir™
Experimental: Simeprevir/TMC647055 + RTV
Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
Drug: IDX719
IDX719 will be supplied as a 50 mg tablet for oral administration.
Drug: Simeprevir
Simeprevir will be supplied as 75 mg capsules for oral administration.
Other Names:
  • Olysio™
Drug: TMC647055
TMC647055 will be supplied as 150 mg capsules for oral administration.
Drug: RTV
RTV will be supplied as 80 mg/mL solution for oral administration.
Other Names:
  • Norvir™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observed maximum plasma drug concentration (Cmax)
Time Frame: Up to 14 days
Up to 14 days
Time to maximum concentration (Tmax)
Time Frame: Up to 14 days
Up to 14 days
Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
Time Frame: Up to 14 days
Up to 14 days
Predose trough concentration (Ctrough)
Time Frame: Up to 14 days
Up to 14 days
Apparent terminal elimination rate constant
Time Frame: Up to 14 days
Up to 14 days
Observed terminal half-life (T1/2)
Time Frame: Up to 14 days
Up to 14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants experiencing serious adverse events (SAEs)
Time Frame: Up to 28 days
Up to 28 days
Percentage of participants experiencing adverse events (AEs)
Time Frame: Up to 28 days
Up to 28 days
Percentage of participants with Grade 1-4 laboratory abnormalities
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

July 22, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1894-007
  • IDX-06A-007 (Other Identifier: Idenix Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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