NCT01813552

To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Samatasvir	Samatasvir 150 mg oral tablets (50mg x 3), single dose
DRUG	Omeprazole	40 mg delayed-release oral capsules, once daily
DRUG	Ritonavir	100 mg oral tablets, once daily

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-03-19
• Last updated: 2016-01-22