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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6552-003 | Other Identifier | MSD |
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This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6552-Placebo-Modafinil | Experimental | Participants were treated in period 1 with MK-6552; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. |
|
| MK-6552-Modafinil-Placebo | Experimental | Participants were treated in period 1 with MK-6552; in period 2 with Modafinil; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. |
|
| Placebo-Modafinil-MK-6552 | Experimental | Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with Modafinil; and in period 3 with MK-6552; with a 7-day washout between each period. |
|
| Placebo-MK-6552-Modafinil | Experimental | Participants were treated in period 1 with placebos to Modafinil and MK-6552; in period 2 with MK-6552; and in period 3 with Modafinil; with a 7-day washout between each period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6552 | Drug | MK-6552 gelatin coated capsules taken orally two times 8 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants with an Adverse Event (AE) | Percentage of participants with at least one AE | Up to Day 30 |
| Participants who discontinued from study due to an AE | Percentage of participants who discontinued from study due to an AE | Day 1 |
| Maintenance of Wakefulness Test (MWT) for MK-6552 | Sleep latency of MWT for MK-6552 compared with placebo | Postdose time to maximum plasma concentration (Tmax) (at designated timepoints up to 24 hours postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration=time curve (AUC) for plasma MK-6552 | AUC for plasma MK-6552 from 0-24 hours postdose | At designated timepoints up to 24 hours postdose |
| Concentration of plasma MK-6522 at Tmax following morning (AM) dose |
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Inclusion Criteria:
Criteria include but are not limited to the following:
Exclusion Criteria:
Criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroTrials Research Inc (Site 0001) | Atlanta | Georgia | 30328 | United States | ||
| Clinilabs (Site 0003) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Modafinil-MK-6552-Plaebo | Experimental | Participants were treated in period 1 with Modafinil; in period 2 withMK-6552; and in period 3 with placebos to Modafinil and MK-6552; with a 7-day washout between each period. |
|
| Modafinil-Plaebo-MK-6552 | Experimental | Participants were treated in period 1 with Modafinil; in period 2 with placebos to Modafinil and MK-6552; and in period 3 with MK-6552; with a 7-day washout between each period. |
|
| MK-6552 placebo | Drug | MK-6552 placebo gelatin coated capsules taken orally two times 8 hours apart |
|
| Modafinil | Drug | Modafinil tablet taken once orally |
|
| Modafinil placebo | Drug | Modafinil placebo tablet taken once orally |
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Plasma concentration of MK-6552 at Tmax following AM dose
| Tmax following AM dose (at designated timepoints up to 24 hours postdose) |
| Concentration of plasma MK-6522 at Tmax following afternoon (PM) dose | Plasma concentration of MK-6552 at Tmax following PM dose | Tmax following PM dose (at designated timepoints up to 24 hours postdose) |
| Concentration of plasma MK-6552 8 hours (C8h) after first dose | C8h of plasma MK-6552 after first dose | 8 hours |
| Concentration of plasma MK-6552 24 hours (C24h) after first dose | C24h of plasma MK-6552 after first dose | 24 hours |
| MWT for Modafinil | Sleep latency of MWT for Modafinil compared with placebo | 2 hours postdose |
| Eatontown |
| New Jersey |
| 07724 |
| United States |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |