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OpenTrials
Active, not recruiting

NCT Number: NCT07661108

A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)

Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.

The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–55 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

  • Be in good health
  • Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive

Exclusion criteria

  • Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
  • Has a history of cancer (malignancy)
  • Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)

Treatment and study plan

MK-8527

Drug

Oral tablet

Probenecid

Drug

Oral tablet

Itraconazole

Drug

Oral solution

Primary outcomes

  1. Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

  2. Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

  3. Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.

Secondary outcomes

  1. Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

  2. Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

  3. Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

  4. Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

  5. Part 1: Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.

  6. Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

  7. Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.

  8. Part 2: Tmax of MK-8527 in Plasma with and without Probenecid

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

  9. Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

  10. Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.

  11. Part 2: Urine Concentration at 72 Hours of MK-8527

    Time frame: At designated timepoints (up to 72 hours postdose)

    Urine samples will be collected to estimate the urine concentration of MK-8527.

  12. Part 2: Renal Clearance of MK-8527

    Time frame: At designated timepoints (up to 72 hours postdose)

    Urine samples will be collected to estimate the renal clearance of MK-8527.

  13. Part 2: Number of Participants Who Experience an AE

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.

  14. Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

  15. Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.

  16. Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.

  17. Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.

  18. Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole

    Time frame: Predose and at designated timepoints (up to 336 hours postdose)

    Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.

  19. Part 3: Urine Concentration at 72 Hours of MK-8527

    Time frame: At designated timepoints (up to 72 hours postdose)

    Urine samples will be collected to estimate the urine concentration of MK-8527.

  20. Part 3: Renal Clearance of MK-8527

    Time frame: At designated timepoints (up to 72 hours postdose)

    Urine samples will be collected to estimate the renal clearance of MK-8527.

  21. Part 3: Number of Participants Who Experience an AE

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience AE will be reported.

  22. Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 43 days

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Sep 3, 2026

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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