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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4646-004 | Other Identifier | MSD |
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Researchers have designed a new study medicine called MK-4646 as a new way to treat human immunodeficiency virus (HIV). Rifabutin is a medication used to treat tuberculosis (TB).
Researchers want to learn about MK-4646 when taken at the same time as Rifabutin.
They want to:
Measure a person's blood to find out if the amount of MK-4646 in the blood is the same when MK-4646 is taken alone or with Rifabutin Learn about the safety of MK-4646 when taken alone or with Rifabutin and if people tolerate it
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4646 | Experimental | On Period 1 Day 1, a single oral dose of MK-4646 will be administered. |
|
| MK-4646 with Rifabutin | Experimental | Rifabutin will be administered orally once daily from Period 2 Day 1 through Period 2 Day 16. A single oral dose of MK-4646 will be administered on Period 2 Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4646 | Drug | Oral Capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of MK-4646 in Plasma | Blood samples will be collected to determine the AUC0-inf of MK-4646 in plasma. | At designated timepoints (up to approximately 3 days post dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE will be reported. |
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The main inclusion criteria include but are not limited to:
The main exclusion criteria include but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp and Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortea CRU Madison ( Site 0001) | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D017828 | Rifabutin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifabutin |
| Drug |
Oral Capsule |
|
| Up to approximately 5 weeks |
| Number of Participants Who Discontinue Study Treatment 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 3 weeks |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |