A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)
August 20, 2025 updated by: Merck Sharp & Dohme LLC
A Clinical Study to Evaluate the Effect of Multiple Doses of Efavirenz on Single-Dose Pharmacokinetics of MK-7602 in Healthy Participants
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Fortrea Clinical Research Unit Inc ( Site 0001)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1: MK-7602 + Efavirenz
Participants will be administered MK-7602 and efavirenz.
|
Capsule
Tablet
Other Names:
|
|
Experimental: Part 2, Sequence 1: Fasted→Moderate-Fat Meal→Low-Fat Meal
Participants will be administered MK-7602 in the fasted state, then with a moderate-fat meal, then with a low-fat meal.
|
Capsule
|
|
Experimental: Part 2, Sequence 2: Fasted→Low-Fat Meal→Moderate-Fat Meal
Participants will be administered MK-7602 in the fasted state, then with a low-fat meal, then with a moderate-fat meal.
|
Capsule
|
|
Experimental: Part 2, Sequence 3: Moderate-Fat Meal→Low-Fat Meal→Fasted
Participants will be administered MK-7602 with a moderate-fat meal, then with a low-fat meal, then in the fasted state.
|
Capsule
|
|
Experimental: Part 2, Sequence 4: Moderate-Fat Meal→Fasted→Low-Fat Meal
Participants will be administered MK-7602 with a moderate-fat meal, then in the fasted state, then with a low-fat meal.
|
Capsule
|
|
Experimental: Part 2, Sequence 5: Low-Fat Meal→Fasted→Moderate-Fat Meal
Participants will be administered MK-7602 with a low-fat meal, then in the fasted state, then with a moderate-fat meal.
|
Capsule
|
|
Experimental: Part 2, Sequence 6: Low-Fat Meal→Moderate-Fat Meal→Fasted
Participants will be administered MK-7602 with a low-fat meal, then with a moderate-fat meal, then in the fasted state.
|
Capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-7602
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: Predose and at designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
Blood samples will be collected to determine the t1/2 of MK-7602.
|
At designated time points (up to 4 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: 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.
|
Up to approximately 10 weeks
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: 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.
|
Up to approximately 10 weeks
|
|
Part 2: AUC0-Inf of MK-7602
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: Predose and at designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
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
Time Frame: At designated time points (up to 4 weeks)
|
Blood samples will be collected to determine the t1/2 of MK-7602.
|
At designated time points (up to 4 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2025
Primary Completion (Actual)
August 12, 2025
Study Completion (Actual)
August 12, 2025
Study Registration Dates
First Submitted
January 21, 2025
First Submitted That Met QC Criteria
January 21, 2025
First Posted (Actual)
January 28, 2025
Study Record Updates
Last Update Posted (Actual)
August 22, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Anti-Infective Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Antiviral Agents
- Cytochrome P-450 Enzyme Inhibitors
- Reverse Transcriptase Inhibitors
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2C19 Inhibitors
- Efavirenz
Other Study ID Numbers
- 7602-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.