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This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4305 40 mg | Experimental | Day 1 and Day 8- 4 x 10 mg MK-4305 and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 |
|
| MK-4305 20 mg | Experimental | Day 1 and Day 8- 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 2 x 10 mg MK-4305 and 2 x 10 mg MK-4305 matching placebo |
|
| Zopiclone 7.5 mg | Active Comparator | Day 1 and Day 8- 1 x 7.5 mg zopiclone and 4 x 10 mg MK-4305 matching placebo; Days 2-7- 4 x 10 mg MK-4305 matching placebo |
|
| Placebo | Placebo Comparator | Day 1 and Day 8- 4 x 10 mg MK-4305 matching placebo and 1 x 7.5 mg zopiclone grossly matching placebo; Days 2-7 - 4 x 10 mg MK-4305 matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4305 40 mg | Drug | 4 x 10 mg MK-4305 tablets |
| |
| MK-4305 20 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo | Day 2 | |
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo | Day 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Sharp & Dohme B.V. | Haarlem | 2031 BN | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26039969 | Background | Vermeeren A, Sun H, Vuurman EF, Jongen S, Van Leeuwen CJ, Van Oers AC, Palcza J, Li X, Laethem T, Heirman I, Bautmans A, Troyer MD, Wrishko R, McCrea J. On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers. Sleep. 2015 Nov 1;38(11):1803-13. doi: 10.5665/sleep.5168. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
| C515050 | zopiclone |
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| Drug |
2 x 10 mg MK-4305 tablets |
|
| Zopiclone | Drug | 1 x 7.5 mg Zopiclone tablet |
|
|
| Grossly Matching Placebo for Zopiclone | Drug | Grossly Matching Placebo for Zopiclone |
|
| Matching Placebo for MK-4305 | Drug | Matching Placebo for MK-4305 |
|
| Mean differences of standard deviation of lateral position (SDLP) on highway driving between zopiclone and placebo | Day 9 |
| Mean standard deviation of speed (SDS) on highway driving (MK-4305 versus placebo) | Day 2 and Day 9 |
| Word learning test (MK-4305 versus placebo) | Day 2 and Day 9 |
| Body sway area: Area of the 95% confidence ellipse enclosing the center of pressure (A95) (MK-4305 versus placebo) | Day 2 and Day 9 |
| Number of participants with adverse events | Up to 14 days after last dose |
| Number of participants discontinued from study due to adverse events | Up to 14 days after last dose |
| D001523 |
| Mental Disorders |