NCT01937975

The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)

An Open-Label Study to Investigate the Pharmacokinetics of MK-5172 and MK-8742 in Subjects With Renal Insufficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.

Conditions

• Chronic Hepatitis C
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Grazoprevir	100 mg oral tablet administered once a day for 10 days
DRUG	Elbasvir	50 mg oral tablet administered once a day for 10 days

Timeline

• Start date: 2013-09-06
• Primary completion: 2013-12-17
• Completion: 2013-12-17
• First posted: 2013-09-10
• Last updated: 2019-06-12
• Results posted: 2016-03-04