Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
Conditions
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.
Interventions
DRUGMK-8527
Administered orally
DRUGRifampin
Administered orally
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Blood samples will be collected to determine AUC0-last of MK-8527 in plasma. |
| 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) | Blood samples will be collected to determine AUC0-336 of MK-8527 in plasma. |
| Maximum Plasma Concentration (Cmax) of MK-8527 | At designated time points (up to approximately 2 weeks) | Blood samples will be collected to determine Cmax of MK-8527 in plasma. |
| Time to Maximum Plasma Concentration (Tmax) of MK-8527 | At designated time points (up to approximately 2 weeks) | Blood samples will be collected to determine Tmax of MK-8527 in plasma. |
| Terminal Elimination Half-Life (T1/2) of MK-8527 | At designated time points (up to approximately 2 weeks) | Blood samples will be collected to determine t1/2 of MK-8527 in plasma. |
| Apparent Clearance (CL/F) of MK-8527 | At designated time points (up to approximately 2 weeks) | Blood samples will be collected to determine CL/F of MK-8527 in plasma. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | At designated time points (up to approximately 2 weeks) | Blood samples will be collected to determine Vz/F of MK-8527 in plasma. |
| Number of Participants Who Experience an Adverse Event (AE) | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. |
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed