NCT01157104

A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)

A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	IDX320	IDX320 400 mg in tablets (8x50 mg) administered orally once daily
DRUG	IDX184	IDX184 100 mg in capsules (2x50 mg) administered orally once daily
DRUG	IDX184 placebo	IDX184 matching placebo in capsules administered orally once daily
DRUG	IDX320 placebo	IDX320 matching placebo in tablets administered orally once daily

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2010-07-05
• Last updated: 2016-01-22