A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Efavirenz; Drug: MK-7602

Study type: Interventional

Funder types: Industry

Identifiers

NCT06797674

7602-005

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 7 patient groups

Part 1: MK-7602 + Efavirenz

Experimental group

Description:

Participants will be administered MK-7602 and efavirenz.

Treatment:

Drug: MK-7602

Drug: Efavirenz

Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal

Experimental group

Description:

Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal.

Treatment:

Drug: MK-7602

Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal

Experimental group

Description:

Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal.

Treatment:

Drug: MK-7602

Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted

Experimental group

Description:

Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state.

Treatment:

Drug: MK-7602

Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal

Experimental group

Description:

Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal.

Treatment:

Drug: MK-7602

Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal

Experimental group

Description:

Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal.

Treatment:

Drug: MK-7602

Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted

Experimental group

Description:

Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state.

Treatment:

Drug: MK-7602