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NCT Number: NCT07600775

A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)

Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI).

The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV Pre-Exposure Prophylaxis Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • Has a diagnosis of untreated latent tuberculosis infection (LTBI)
  • Has no symptoms of active tuberculosis (TB)
  • Has never received treatment for TB or LTBI
  • Other than having LTBI, is in good health

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

  • Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
  • Has a current or anticipated immunocompromised state
  • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
  • Has a history of cancer (malignancy)
  • Has a history of active TB
  • Has positive test results for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus

Treatment and study plan

MK-8527

Drug

Administered orally

Rifampin

Drug

Administered orally

Primary outcomes

  1. Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

    Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.

Secondary outcomes

  1. Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

    Blood samples will be collected to determine AUC0-last of MK-8527 in plasma.

  2. Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

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

  3. Maximum Plasma Concentration (Cmax) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

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

  4. Time to Maximum Plasma Concentration (Tmax) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

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

  5. Terminal Elimination Half-Life (T1/2) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

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

  6. Apparent Clearance (CL/F) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

    Blood samples will be collected to determine CL/F of MK-8527 in plasma.

  7. Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527

    Time frame: At designated time points (up to approximately 2 weeks)

    Blood samples will be collected to determine Vz/F of MK-8527 in plasma.

  8. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 8 weeks

    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 an AE will be reported.

  9. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 8 weeks

    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 Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
Jul 2, 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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