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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: Simeprevir; Drug: IDX719; Drug: RTV; Drug: TMC647055

Study type: Interventional

Funder types: Industry

Identifiers

NCT01907724

IDX-06A-007 (Other Identifier)

1894-007

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

IDX719 + RTV

Experimental group

Description:

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.

Treatment:

Drug: IDX719

Drug: RTV

Drug: TMC647055

Drug: Simeprevir

Simeprevir/TMC647055 + RTV

Experimental group

Description:

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.

Treatment:

Drug: IDX719

Drug: RTV

Drug: TMC647055

Drug: Simeprevir