A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
- Registration Number
- NCT06665230
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MK-6552 + Modafinil MK-6552 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. MK-6552 + Modafinil Modafinil 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.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Alliance for Multispecialty Research, LLC (Site 0001)
🇺🇸Knoxville, Tennessee, United States