NCT02910739

An Open-Label Study Investigating MK-8931 in Participants With Mild and Moderate Hepatic Insufficiency (MK-8931-016)

A Two-Part, Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-8931 When Administered to Subjects With Mild and Moderate Hepatic Insufficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study consists of Part I and an optional Part II. The purpose of Part I is to compare the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of 40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that of healthy matched controls. An interim safety and pharmacokinetic analysis on the basis of Part I will be performed in order to support the decision to continue with the optional Part II. If a decision to continue with Part II is made, participants with mild HI will be enrolled to receive a single oral dose of 40mg MK-8931. If any healthy participants from Part I do not meet the matching criteria for Part II additional healthy participants will be enrolled.

Conditions

• Amnestic Mild Cognitive Impairment
• Alzheimer's Disease
• Prodromal Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	MK-8931	MK-8931 40 mg

Timeline

• Start date: 2016-10-11
• Primary completion: 2017-04-03
• Completion: 2017-04-12
• First posted: 2016-09-22
• Last updated: 2018-10-01
• Results posted: 2018-10-01