Healthy
Conditions
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.
Interventions
DRUGMK-7602
Capsule
DRUGEfavirenz
Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Part 1 has a single arm. Part 2 will enroll participants in a crossover design, randomized between 6 different treatment sequences.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed