Trials / Completed
CompletedNCT01092780
Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)
An Active-Comparator Controlled Single Dose Study to Evaluate the Pharmacodynamics/Efficacy of MK-7288 in Sleep Apnea Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-05-26
- Primary completion
- 2011-05-31
- Completion
- 2011-05-31
- First posted
- 2010-03-25
- Last updated
- 2018-11-08
- Results posted
- 2016-04-22
Source: ClinicalTrials.gov record NCT01092780. Inclusion in this directory is not an endorsement.