NCT01043926

Pharmacokinetics of Suvorexant in Participants With Hepatic Insufficiency (MK-4305-017)

A Single Dose Study to Investigate the Pharmacokinetics of MK-4305 in Patients With Hepatic Insufficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will determine whether the plasma concentration-time profile and pharmacokinetics (PK) of suvorexant (MK-4305) in participants with moderate and mild hepatic insufficiency are similar to those observed in healthy participants.

Detailed description

Study Design: This study plans to enroll 16 participants in Part I (8 participants with moderate hepatic insufficiency and 8 healthy participants) and 16 participants in Part II (8 participants with mild hepatic insufficiency and 8 healthy participants). Part II will be conducted only if the primary hypothesis is not met and there is a significant difference in the PK of suvorexant between healthy participants and moderate hepatic insufficiency participants in Part I.

Conditions

• Insomnia
• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Suvorexant	single 20 mg dose of suvorexant will be administered as 2 x 10 mg film coated tablets on Day 1 after an overnight fast with water.

Timeline

• Start date: 2010-02-22
• Primary completion: 2010-04-14
• Completion: 2010-04-14
• First posted: 2010-01-07
• Last updated: 2018-09-21
• Results posted: 2014-08-29