Clinical trial NCT06665230: A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)
Official title: A Three-Period Study to Evaluate the Effects of Modafinil on the Single-Dose Pharmacokinetics of MK-6552 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Narcolepsy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer

Primary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 1 month
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 19 days
measure: High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: High Dose Modafinil Effect: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6552
timeFrame: At designated timepoints (up to approximately 24 hours postdose)
measure: High Dose Modafinil Effect: Time to Maximum Plasma Concentration (Tmax) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: High Dose Modafinil Effect: Maximum Plasma Concentration (Cmax) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 6 Hours Postdose (C6hrs)
timeFrame: At designated timepoints (up to approximately 6 hours postdose)
measure: High Dose Modafinil Effect: Plasma Concentration of MK-6552 at 8 Hours Postdose (C8hrs)
timeFrame: At designated timepoints (up to approximately 8 hours postdose)
measure: High Dose Modafinil Effect: Apparent Clearance (CL/F) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: High Dose Modafinil Effect: Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: High Dose Modafinil Effect: Apparent Terminal Half-life (t1/2) of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
Secondary outcomes:
measure: Low Dose Modafinil Effect: AUC0-inf of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: Low Dose Modafinil Effect: AUC0-24hrs of MK-6552
timeFrame: At designated timepoints (up to approximately 24 hours postdose)
measure: Low Dose Modafinil Effect: Tmax of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: Low Dose Modafinil Effect: Cmax of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: Low Dose Modafinil Effect: C6hrs of MK-6552
timeFrame: At designated timepoints (up to approximately 6 hours postdose)
measure: Low Dose Modafinil Effect: C8hrs of MK-6552
timeFrame: At designated timepoints (up to approximately 8 hours postdose)
measure: Low Dose Modafinil Effect: CL/F of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: Low Dose Modafinil Effect: Vz/F of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
measure: Low Dose Modafinil Effect: t1/2 of MK-6552
timeFrame: At designated timepoints (up to approximately 36 hours postdose)
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC (Site 0001)
state: Tennessee
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: