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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-019 | Other Identifier | MSD |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8527 + Rifampin | Experimental | Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Administered orally |
| |
| Rifampin |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Administered orally |
|
Blood samples will be collected to determine AUC0-336 of MK-8527 in plasma. |
| At designated time points (up to approximately 2 weeks) |
| Maximum Plasma Concentration (Cmax) of MK-8527 | Blood samples will be collected to determine Cmax of MK-8527 in plasma. | At designated time points (up to approximately 2 weeks) |
| Time to Maximum Plasma Concentration (Tmax) of MK-8527 | Blood samples will be collected to determine Tmax of MK-8527 in plasma. | At designated time points (up to approximately 2 weeks) |
| Terminal Elimination Half-Life (T1/2) of MK-8527 | Blood samples will be collected to determine t1/2 of MK-8527 in plasma. | At designated time points (up to approximately 2 weeks) |
| Apparent Clearance (CL/F) of MK-8527 | Blood samples will be collected to determine CL/F of MK-8527 in plasma. | At designated time points (up to approximately 2 weeks) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527 | Blood samples will be collected to determine Vz/F of MK-8527 in plasma. | At designated time points (up to approximately 2 weeks) |
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to approximately 8 weeks |
| Number of Participants Who Discontinue Study Treatment Due to an AE | 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. | Up to approximately 8 weeks |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |