NCT04676425

A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)

A 2-part, Open-label, Single-dose Study to Investigate the Influence of Hepatic Impairment on the Pharmacokinetics of MK-8189

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic impairment to healthy participants.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	MK-8189	Administered at a dose of 4 mg via oral tablet

Timeline

• Start date: 2021-03-17
• Primary completion: 2022-01-16
• Completion: 2022-01-25
• First posted: 2020-12-21
• Last updated: 2023-10-06
• Results posted: 2023-10-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study