At a glance
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An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients
In Brief
A Phase 1 clinical trial evaluating MK-7288, Placebo to MK-7288, and 2 other interventions for Apnea, Sleep. Completed, enrolled 56 participants.
Detailed 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).
Study Details
Timeline
Interventions
one or two 10 mg capsules, orally, single dose
one or two capsules, orally, single dose
two 100 mg tablets, orally, single dose
two 100 mg tablets, orally, single dose