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Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)

NCT01092780 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-11-08

Study results available
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Summary

This is a study of the safety and efficacy of MK-7288 for the treatment of excessive daytime sleepiness (EDS) in participants with obstructive sleep apnea (OSA)/hypopnea syndrome (HS) who are compliant with effective nasal continuous positive airway pressure (nCPAP) therapy. The goal of this study is to determine the effect of MK-7288 after single dose administration on promoting wakefulness as measured by sleep latency on Maintenance of Wakefulness Tests, and on driving performance as measured by standard deviation of lane position in simulated driving (country vigilance driving).

Conditions

  • Apnea, Sleep

Interventions

DRUG

MK-7288

one or two 10 mg capsules, orally, single dose

DRUG

Placebo to MK-7288

one or two capsules, orally, single dose

DRUG

Modafinil

two 100 mg tablets, orally, single dose

DRUG

Placebo to modafinil

two 100 mg tablets, orally, single dose

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-26
Primary Completion
2011-05-31
Completion
2011-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092780 on ClinicalTrials.gov