A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)
- Registration Number
- NCT06797674
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The goal of the study is to learn what happens to levels of MK-7602 in a healthy person's body over time. Researchers will compare what happens to MK-7602 in the body when it is given with or without another medicine called efavirenz, and when it is given with or without a meal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
The key inclusion criteria include but are not limited to the following:
- Has a body-mass index (BMI) of 18 to 32 kg/m^2.
The key 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 seizures) abnormalities or diseases.
- Has a history of cancer (malignancy)
- Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: MK-7602 + Efavirenz MK-7602 Participants will be administered MK-7602 and efavirenz. Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal MK-7602 Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal. Part 1: MK-7602 + Efavirenz Efavirenz Participants will be administered MK-7602 and efavirenz. Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal MK-7602 Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal. Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted MK-7602 Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state. Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal MK-7602 Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal. Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal MK-7602 Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal. Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted MK-7602 Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the Cmax of MK-7602.
Time to Maximum Plasma Concentration (Tmax) of MK-7602 Predose and at designated time points (up to 4 weeks) Blood samples will be collected to determine the Tmax of MK-7602.
Plasma Concentration at 24 Hours (C24) of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the C24 of MK-7602.
Apparent Terminal Half-life (t1/2) of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the t1/2 of MK-7602.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the AUC0-inf of MK-7602.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the AUC0-24hr of MK-7602.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 10 weeks 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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 10 weeks 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. The number of participants who discontinue study treatment due to an AE will be reported.
Part 2: AUC0-Inf of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the AUC0-inf of MK-7602.
Part 2: AUC0-24hrs of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the AUC0-24hr of MK-7602.
Part 2: Cmax of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the Cmax of MK-7602.
Part 2: Tmax of MK-7602 Predose and at designated time points (up to 4 weeks) Blood samples will be collected to determine the Tmax of MK-7602.
Part 2: C24 of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the C24 of MK-7602.
Part 2: t1/2 of MK-7602 At designated time points (up to 4 weeks) Blood samples will be collected to determine the t1/2 of MK-7602.
Related Research Topics
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Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc ( Site 0001)
🇺🇸Daytona Beach, Florida, United States