drugset / Trial / NCT01930058

Safety, Pharmacokinetics, and Pharmacodynamics of MK-8876 in Participants With Hepatitis C Infection (MK-8876-003)

NCT01930058 ↗

Phase 1 Completed 9 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This adaptive design study will evaluate the safety, pharmacokinetics, and effect on hepatitis C virus (HCV) RNA levels of multiple doses of MK-8876 in participants with HCV infection. The study will consist of 4 parts evaluating participants infected with specific hepatitis C virus genotypes and up to 10 panels allowing for additional participants to enroll in each panel as specified in the study analysis. The hypothesis evaluated in the study is that a ≥2.5 log IU/mL reduction in HCV RNA from Baseline will accompany multiple dose administration of MK-8876 in participants with HCV infection.

Timeline

Start
2013-10-02
Primary completion
2014-05-05
Completion
2014-05-05

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-8876 Small molecule 150 mg Oral
Subject MK-8876 Small molecule 800 mg Oral