CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
MK-1064 +2 moredrug
Likely dose
MK-1064 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02549027
NCT02549027Phase 1Completed

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

Merck Sharp & Dohme LLC·interventional·Posted Sep 14, 2015·Updated Oct 23, 2018

In Brief

A Phase 1 clinical trial evaluating MK-1064, MK-6096, and 1 other intervention for Polysomnography. Completed, enrolled 20 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolysomnography
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartNov 6, 2009
Primary CompletionApr 6, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.8 years ago

Interventions

MK-1064drug

Oral MK-1064 tablets (10 and 50 mg strengths)

MK-6096drug

Oral MK-6096 tablets (5 mg strength)

Placebodrug

Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)