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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8527-014 | Other Identifier | MSD |
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Researchers are looking for new medicines to prevent Human Immunodeficiency Virus Type 1 (HIV-1) infection. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system. Medicines to prevent HIV-1 infection are called pre-exposure prophylaxis (PrEP). Some people may have trouble following a PrEP plan because it involves either taking medicine everyday by mouth or getting injections (shots) often.
MK-8527 is a study medicine designed to prevent HIV-1 infection. MK-8527 is different from standard (usual) PrEP because it is taken once a month, by mouth, as a tablet.
The goal of this study is to learn if taking a higher-than-normal dose of MK-8527 increases the QT interval (a measure of heart rhythm) by a certain amount.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-8527 PLUS Moxifloxacin and Placebo | Experimental | Participants receive a single dose of MK-8527 followed by a single dose of moxifloxacin and a single dose of placebo depending on randomization. |
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| Moxifloxacin PLUS MK-8527 and Placebo | Experimental | Participants receive a single dose of moxifloxacin followed by a single dose of MK-8527 and a single dose of placebo depending on randomization. |
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| Placebo PLUS MK-8527 and Moxifloxacin | Experimental | Participants receive a single dose of placebo followed by a single dose of MK-8527 and a single dose of moxifloxacin depending on randomization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-8527 | Drug | Oral administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in QT interval corrected for heart rate (QTc) following MK-8527 administration | Change from Baseline in QTc following MK-8527 administration will be reported. | Baseline and up to approximately 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported. | Up to approximately 7 weeks |
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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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hassman Research Institute Marlton Site ( Site 0001) | Marlton | New Jersey | 08053 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Oral administration |
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| Placebo | Drug | Oral administration |
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| Number of participants who discontinue study intervention due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported. | Up to approximately 7 weeks |
| Change from Baseline in QTc following moxifloxacin administration | Change from Baseline in QTc following moxifloxacin administration will be reported. | Baseline and up to approximately 24 hours |
| Area Under the Plasma Concentration-Time curve From Time 0 to 24 hours (AUC0-24) of MK-8527 | Blood samples will be collected at multiple time points to estimate AUC0-24 of MK-8527 | At designated timepoints (up to 24 hours postdose) |
| Area Under the Plasma Concentration-Time curve From Time 0 to 168 hours (AUC0-168) of MK-8527 | Blood samples will be collected at multiple time points to estimate AUC0-168 of MK-8527 | At designated timepoints (up to 168 hours postdose) |
| Area Under the Plasma Concentration-Time curve From Time 0 to infinity (AUC0-inf) of MK-8527 | Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 | At designated timepoints (up to approximately 7 weeks) |
| Maximum plasma concentration (Cmax) of MK-8527 | Blood samples will be collected at multiple time points to estimate Cmax of MK-8527 | At designated timepoints (up to approximately 7 weeks) |
| Time to maximum plasma concentration (Tmax) of MK-8527 | Blood samples will be collected at multiple time points to estimate Tmax of MK-8527 | At designated timepoints (up to approximately 7 weeks) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |