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Completed

NCT Number: NCT06797674

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

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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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc ( Site 0001)

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MK-7602

Drug

Capsule

Efavirenz

Drug

Tablet

Other names: MK-0831

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Effect of Multiple Doses of Efavirenz on Single-Dose Pharmacokinetics of MK-7602 in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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