Clinical trial NCT06797674: A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)
Official title: A Clinical Study to Evaluate the Effect of Multiple Doses of Efavirenz on Single-Dose Pharmacokinetics of MK-7602 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part 1 has a single arm. Part 2 will enroll participants in a crossover design, randomized between 6 different treatment sequences.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Maximum Plasma Concentration (Cmax) of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Time to Maximum Plasma Concentration (Tmax) of MK-7602
timeFrame: Predose and at designated time points (up to 4 weeks)
measure: Plasma Concentration at 24 Hours (C24) of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Apparent Terminal Half-life (t1/2) of MK-7602
timeFrame: At designated time points (up to 4 weeks)
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 10 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 10 weeks
measure: Part 2: AUC0-Inf of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Part 2: AUC0-24hrs of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Part 2: Cmax of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Part 2: Tmax of MK-7602
timeFrame: Predose and at designated time points (up to 4 weeks)
measure: Part 2: C24 of MK-7602
timeFrame: At designated time points (up to 4 weeks)
measure: Part 2: t1/2 of MK-7602
timeFrame: At designated time points (up to 4 weeks)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit Inc ( Site 0001)
state: Florida
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: