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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8507-012 | Other Identifier | MSD |
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Researchers are looking for new treatments for HIV-1 (human immunodeficiency virus type 1) that are safe, well-tolerated, and can be taken less often. HIV-1 is the most common type of HIV, which is a virus that attacks cells of the immune system.
Ulonivirine (MK-8507) is a study medicine designed to treat HIV-1
The goal of this study is to learn if ulonivirine does not increase the QT interval (a measure of heart rhythm on an electrocardiogram) above a certain amount. Researchers also want to learn what happens to the amount of ulonivirine in a healthy person's body over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin 400 mg + Placebo (Arm 1) | Experimental | Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR ulonivirine dose matched placebo + moxifloxacin 400 mg. |
|
| Ulonivirine Dose 1 + Placebo (Arm 2) | Experimental | Participants will receive ulonivirine dose matched placebo + moxifloxacin dose matched placebo OR moxifloxacin dose matched placebo + ulonivirine Dose 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulonivirine | Drug | Oral tablet |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Ulonivirine Administration | Change from baseline in QTc following ulonivirine administration will be reported. | Baseline and up to approximately 24 hours |
| Plasma Concentration of Ulonivirine at QTc Intervals (Cqtc) | Blood samples will be collected to determine the Cqtc of ulonivirine. | At designated timepoints (up to approximately 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) Following Moxifloxacin Administration | Change from baseline in QTc following moxifloxacin administration will be reported. | Baseline to up to approximately 24 hours |
| Plasma concentration of Moxifloxacin at QTc intervals (Cqtc) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services (0001) | San Antonio | Texas | 78209 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| C000723084 | ulonivirine |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Oral tablet |
|
| Ulonivirine Placebo | Drug | Oral tablet |
|
| Moxifloxacin Placebo | Drug | Oral tablet |
|
Blood samples will be collected to determine the Cqtc of moxifloxacin. |
| At designated timepoints (up to approximately 24 hours) |
| Maximum Plasma Concentration (Cmax) of Moxifloxacin | Blood samples will be collected to determine the Cmax of moxifloxacin. | At designated timepoints (up to approximately 168 hours) |
| Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ulonivirine | Blood samples will be collected to determine the AUC0-24 of ulonivirine. | At designated timepoints (up to 168 hours) |
| Maximum Plasma Concentration (Cmax) of Ulonivirine | Blood samples will be collected to determine the Cmax of ulonivirine. | At designated timepoints (up to 168 hours) |
| Time to Maximum Plasma Concentration (Tmax) of Ulonivirine | Blood samples will be collected to determine the Tmax of ulonivirine. | At designated timepoints (up to 168 hours) |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |