A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experience an Adverse Event (AE)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MK-6552 + 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.
Intervention: MK-6552 (Drug)
MK-6552 + 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.
Intervention: Modafinil (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Low Dose Modafinil Effect: AUC0-inf of MK-6552(At designated timepoints (up to approximately 36 hours postdose))
- Low Dose Modafinil Effect: AUC0-24hrs of MK-6552(At designated timepoints (up to approximately 24 hours postdose))
- Low Dose Modafinil Effect: Tmax of MK-6552(At designated timepoints (up to approximately 36 hours postdose))
- Low Dose Modafinil Effect: Cmax of MK-6552(At designated timepoints (up to approximately 36 hours postdose))
- Low Dose Modafinil Effect: C6hrs of MK-6552(At designated timepoints (up to approximately 6 hours postdose))
- Low Dose Modafinil Effect: C8hrs of MK-6552(At designated timepoints (up to approximately 8 hours postdose))
- Low Dose Modafinil Effect: CL/F of MK-6552(At designated timepoints (up to approximately 36 hours postdose))
- Low Dose Modafinil Effect: Vz/F of MK-6552(At designated timepoints (up to approximately 36 hours postdose))
- Low Dose Modafinil Effect: t1/2 of MK-6552(At designated timepoints (up to approximately 36 hours postdose))