NCT02549027

A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)

A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.

Conditions

• Polysomnography

Interventions

Type	Name	Description
DRUG	MK-1064	Oral MK-1064 tablets (10 and 50 mg strengths)
DRUG	MK-6096	Oral MK-6096 tablets (5 mg strength)
DRUG	Placebo	Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)

Timeline

• Start date: 2009-11-06
• Primary completion: 2010-04-06
• Completion: 2010-04-06
• First posted: 2015-09-14
• Last updated: 2018-10-23
• Results posted: 2015-12-10