NCT01907724

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-07-25
• Last updated: 2016-01-26