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

Phase 1

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: IDX719; Drug: Simeprevir; Drug: TMC647055; Drug: RTV

• Registration Number: NCT01907724
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-07-22
• Study First Posted: 2013-07-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simeprevir/TMC647055 + RTV	IDX719	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.
IDX719 + RTV	IDX719	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.
Simeprevir/TMC647055 + RTV	TMC647055	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.
IDX719 + RTV	TMC647055	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.
IDX719 + RTV	Simeprevir	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.
Simeprevir/TMC647055 + RTV	Simeprevir	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.
IDX719 + RTV	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.
Simeprevir/TMC647055 + RTV	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants experiencing serious adverse events (SAEs)	Up to 28 days
Percentage of participants experiencing adverse events (AEs)	Up to 28 days
Percentage of participants with Grade 1-4 laboratory abnormalities	Up to 28 days