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

NCT ID: NCT01907724

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IDX719

Intervention Type: DRUG

IDX719 will be supplied as a 50 mg tablet for oral administration.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 mg capsules for oral administration.

TMC647055

Intervention Type: DRUG

TMC647055 will be supplied as 150 mg capsules for oral administration.

RTV

Intervention Type: DRUG

RTV will be supplied as 80 mg/mL solution for oral administration.

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.

Group Type: EXPERIMENTAL

IDX719

Intervention Type: DRUG

IDX719 will be supplied as a 50 mg tablet for oral administration.

Simeprevir

Intervention Type: DRUG

Simeprevir will be supplied as 75 mg capsules for oral administration.

TMC647055

Intervention Type: DRUG

TMC647055 will be supplied as 150 mg capsules for oral administration.

RTV

Intervention Type: DRUG

RTV will be supplied as 80 mg/mL solution for oral administration.

Interventions

IDX719

IDX719 will be supplied as a 50 mg tablet for oral administration.

Intervention Type: DRUG

Simeprevir

Simeprevir will be supplied as 75 mg capsules for oral administration.

Intervention Type: DRUG

TMC647055

TMC647055 will be supplied as 150 mg capsules for oral administration.

Intervention Type: DRUG

RTV

RTV will be supplied as 80 mg/mL solution for oral administration.

Intervention Type: DRUG

Other Intervention Names

Olysio™; Norvir™

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

IDX-06A-007

Identifier Type: OTHER

Identifier Source: secondary_id

1894-007

Identifier Type: -

Identifier Source: org_study_id