Healthy, Narcolepsy
Conditions
Brief summary
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.
Interventions
DRUGMK-6552
Oral administration
DRUGModafinil
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is in good health based on medical history and physical examination * Has a body mass index ≥18 and ≤32 kg/m\^2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of high dose modafinil. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 19 days | 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. |
| High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552 | At designated timepoints (up to approximately 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Tmax of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Cmax of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs) | At designated timepoints (up to approximately 6 hours postdose) | Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs) | At designated timepoints (up to approximately 8 hours postdose) | Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of high dose modafinil |
| High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the CL/F of MK-6552 in the presence of high dose modafinil. |
| High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of high dose modafinil. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Dose Modafinil Effect: AUC0-24hrs of MK-6552 | At designated timepoints (up to approximately 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hrs of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: Tmax of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Tmax of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: Cmax of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Cmax of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: C6hrs of MK-6552 | At designated timepoints (up to approximately 6 hours postdose) | Blood samples will be collected to determine the C6hrs of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: C8hrs of MK-6552 | At designated timepoints (up to approximately 8 hours postdose) | Blood samples will be collected to determine the C8hrs of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: CL/F of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the CL/F of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: Vz/F of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the Vz/F of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: t1/2 of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the t1/2 of MK-6552 in the presence of low dose modafinil. |
| Low Dose Modafinil Effect: AUC0-inf of MK-6552 | At designated timepoints (up to approximately 36 hours postdose) | Blood samples will be collected to determine the AUC0-inf of MK-6552 in the presence of low dose modafinil. |
Countries
United States
Outcome results
None listed