A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
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.
Timeline
- Start
- 2009-11-06
- Primary completion
- 2010-04-06
- Completion
- 2010-04-06
Outcome
Met primary endpoint
registry MK-1064 50 mg vs Placebo; Geometric Mean Ratio 0.24 (90% CI 0.12 to 0.47) NCT02549027 ↗
registry MK-1064 120 mg vs Placebo; Geometric Mean Ratio 0.21 (90% CI 0.10 to 0.41) NCT02549027 ↗
registry MK-1064 250 mg vs Placebo; Geometric Mean Ratio 0.15 (90% CI 0.08 to 0.30) NCT02549027 ↗
registry MK-6096 20 mg vs Placebo; Geometric Mean Ratio 0.05 (90% CI 0.02 to 0.11) NCT02549027 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Filorexant | Small molecule | 20 mg | Oral |
| Subject | MK-1064 | Small molecule | 50 mg | Oral |
| Subject | MK-1064 | Small molecule | 120 mg | Oral |
| Subject | MK-1064 | Small molecule | 250 mg | Oral |
Indications
No indication recorded.