A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
MK-8527
DrugAdministered orally
Rifampin
DrugAdministered orally
Treatment groups
14 Participants
are divided into 1 treatment groupGroup A: MK-8527 + RifampinExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
At designated time points (up to approximately 2 weeks)Secondary outcomes
1
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527
Blood samples will be collected to determine AUC0-last of MK-8527 in plasma.
Time frame
At designated time points (up to approximately 2 weeks)2
Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527
Blood samples will be collected to determine AUC0-336 of MK-8527 in plasma.
Time frame
At designated time points (up to approximately 2 weeks)3
Maximum Plasma Concentration (Cmax) of MK-8527
Blood samples will be collected to determine Cmax of MK-8527 in plasma.
Time frame
At designated time points (up to approximately 2 weeks)4
Time to Maximum Plasma Concentration (Tmax) of MK-8527
Blood samples will be collected to determine Tmax of MK-8527 in plasma.
Time frame
At designated time points (up to approximately 2 weeks)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: