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| ID | Type | Description | Link |
|---|---|---|---|
| MK-6552-005 | Other Identifier | MSD |
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The goal of this study is to learn what happens to MK-6552 in a person's body over time. Researchers will compare what happens to levels of MK-6552 in people's blood when it is taken with and without modafinil. Researchers also want to learn about the safety of MK-6552 taken with and without modafinil and if people tolerate it.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-6552 + Modafinil | Experimental | In Period 1, participants receive MK-6552 orally. In Period 2, participants receive MK-6552 orally plus low dose modafinil orally. In Period 3, participants receive MK-6552 orally plus high dose modafinil orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-6552 | Drug | Oral administration |
| |
| Modafinil |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 1 month |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 19 days |
| High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 | Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552 | Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 24 hours postdose) |
| High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552 | Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Dose Modafinil Effect: AUC0-inf of MK-6552 | Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| Low Dose Modafinil Effect: AUC0-24hrs of MK-6552 |
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Inclusion Criteria
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria
The main exclusion 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 |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC (Site 0001) | Knoxville | Tennessee | 37920 | United States |
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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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| Drug |
Oral administration |
|
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Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil.
| At designated timepoints (up to approximately 36 hours postdose) |
| High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs) | Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 6 hours postdose) |
| High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs) | Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil | At designated timepoints (up to approximately 8 hours postdose) |
| High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552 | Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552 | Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552 | Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of low dose modafinil. |
| At designated timepoints (up to approximately 24 hours postdose) |
| Low Dose Modafinil Effect: Tmax of MK-6552 | Blood samples will be collected to determine the Tmax of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| Low Dose Modafinil Effect: Cmax of MK-6552 | Blood samples will be collected to determine the Cmax of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| Low Dose Modafinil Effect: C6hrs of MK-6552 | Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 6 hours postdose) |
| Low Dose Modafinil Effect: C8hrs of MK-6552 | Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 8 hours postdose) |
| Low Dose Modafinil Effect: CL/F of MK-6552 | Blood samples will be collected to determine the CL/F of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| Low Dose Modafinil Effect: Vz/F of MK-6552 | Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| Low Dose Modafinil Effect: t1/2 of MK-6552 | Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of low dose modafinil. | At designated timepoints (up to approximately 36 hours postdose) |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |