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

NCT07600775 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 8527-019MK-8527-019
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis

Outcome Measures

Primary Outcomes (1)

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

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

  At designated time points (up to approximately 2 weeks)

Secondary Outcomes (9)

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

  At designated time points (up to approximately 2 weeks)

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

  At designated time points (up to approximately 2 weeks)

• Maximum Plasma Concentration (Cmax) of MK-8527

  At designated time points (up to approximately 2 weeks)

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

  At designated time points (up to approximately 2 weeks)

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

  At designated time points (up to approximately 2 weeks)

Study Arms (1)

MK-8527 + Rifampin

EXPERIMENTAL

Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin.

Drug: MK-8527; Drug: Rifampin

Interventions

MK-8527 DRUG

Administered orally

MK-8527 + Rifampin

Rifampin DRUG

Administered orally

MK-8527 + Rifampin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Rifampin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share