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

NCT06797674 | Completed Phase 1 FDA Drug

• 1 other identifier: 7602-005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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)

Secondary Outcomes (8)

• Number of Participants Who Experience an Adverse Event (AE)

  Up to approximately 10 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 10 weeks

• Part 2: AUC0-Inf of MK-7602

  At designated time points (up to 4 weeks)

• Part 2: AUC0-24hrs of MK-7602

  At designated time points (up to 4 weeks)

• Part 2: Cmax of MK-7602

  At designated time points (up to 4 weeks)

Study Arms (7)

Part 1: MK-7602 + Efavirenz

EXPERIMENTAL

Participants will be administered MK-7602 and efavirenz.

Drug: MK-7602; Drug: Efavirenz

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.

Drug: MK-7602

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.

Drug: MK-7602

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.

Drug: MK-7602

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.

Drug: MK-7602

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.

Drug: MK-7602

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.

Drug: MK-7602

Interventions

MK-7602 DRUG

Capsule

Part 1: MK-7602 + Efavirenz; Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal; Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal; Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted; Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal; Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal; Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted

Efavirenz DRUG

Tablet

Also known as: MK-0831

Part 1: MK-7602 + Efavirenz

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Has a body-mass index (BMI) of 18 to 32 kg/m\^2.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc ( Site 0001)

Daytona Beach, Florida, 32117, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

efavirenz

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 has a single arm. Part 2 will enroll participants in a crossover design, randomized between 6 different treatment sequences.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start: February 10, 2025
• Primary Completion: August 12, 2025
• Study Completion: August 12, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)