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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MK-7602 + Efavirenz | Experimental | Participants will be administered MK-7602 and efavirenz. |
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| Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal | Experimental | Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal. |
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| Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal | Experimental | Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal. |
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| Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted | Experimental | Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state. |
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| Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal | Experimental | Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-7602 | Drug | Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7602 | Blood samples will be collected to determine the AUC0-inf of MK-7602. | At designated time points (up to 4 weeks) |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-7602 | Blood samples will be collected to determine the AUC0-24hr of MK-7602. | At designated time points (up to 4 weeks) |
| Maximum Plasma Concentration (Cmax) of MK-7602 | Blood samples will be collected to determine the Cmax of MK-7602. | At designated time points (up to 4 weeks) |
| Time to Maximum Plasma Concentration (Tmax) of MK-7602 | Blood samples will be collected to determine the Tmax of MK-7602. | Predose and at designated time points (up to 4 weeks) |
| Plasma Concentration at 24 Hours (C24) of MK-7602 | Blood samples will be collected to determine the C24 of MK-7602. | At designated time points (up to 4 weeks) |
| Apparent Terminal Half-life (t1/2) of MK-7602 | Blood samples will be collected to determine the t1/2 of MK-7602. | At designated time points (up to 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 10 weeks |
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Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc ( Site 0001) | Daytona Beach | Florida | 32117 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C098320 | efavirenz |
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Part 1 has a single arm. Part 2 will enroll participants in a crossover design, randomized between 6 different treatment sequences.
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| Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal | Experimental | Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal. |
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| Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted | Experimental | Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state. |
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| Efavirenz | Drug | Tablet |
|
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| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 10 weeks |
| Part 2: AUC0-Inf of MK-7602 | Blood samples will be collected to determine the AUC0-inf of MK-7602. | At designated time points (up to 4 weeks) |
| Part 2: AUC0-24hrs of MK-7602 | Blood samples will be collected to determine the AUC0-24hr of MK-7602. | At designated time points (up to 4 weeks) |
| Part 2: Cmax of MK-7602 | Blood samples will be collected to determine the Cmax of MK-7602. | At designated time points (up to 4 weeks) |
| Part 2: Tmax of MK-7602 | Blood samples will be collected to determine the Tmax of MK-7602. | Predose and at designated time points (up to 4 weeks) |
| Part 2: C24 of MK-7602 | Blood samples will be collected to determine the C24 of MK-7602. | At designated time points (up to 4 weeks) |
| Part 2: t1/2 of MK-7602 | Blood samples will be collected to determine the t1/2 of MK-7602. | At designated time points (up to 4 weeks) |