Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-4646 · 3 trials · 2 indications
Blood samples will be collected to determine the AUC0-Inf of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Blood samples will be collected to determine the Cmax of rosuvastatin when MK-4646 is coadministered with rosuvastatin.
Blood samples will be collected to determine the AUC0-inf of MK-4646 in plasma.
Percentage of participants with one or more AEs
Percentage of participants who discontinued study medication due to an AE
Time course of plasma HIV-1 RNA viral load decline.
| Arm | Type | Description |
|---|---|---|
| Treatment A: Rosuvastatin | ACTIVE_COMPARATOR | Participants will receive a single oral dose of rosuvastatin. |
| Treatment B: Rosuvastatin + MK-4646 | EXPERIMENTAL | Participants will receive a single oral dose of rosuvastatin coadministered with MK-4646. |
| 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. |
| MK-4646 Panel A | EXPERIMENTAL | MK-4646 160 mg every 24 hours (q24h) for 7 days |
| MK-4646 Panel B | EXPERIMENTAL | MK-4646 ≤460 mg q24h for 7 days |
| MK-4646 Panel C | EXPERIMENTAL | MK-4646 ≤460 mg q24h for 7 days |
| MK-4646 Panel D | EXPERIMENTAL | MK-4646 ≤460 mg every 12 hours (q12h) for 7 days |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | Oral tablet |
| MK-4646 | DRUG | Oral capsule |
| Rifabutin | DRUG | Oral Capsule |
Inclusion Criteria: * Is in good health before randomization * Has a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive Exclusion Criteria: * Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory...
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MK-4646 is an investigational small molecule being developed by Merck & Company, Inc. for the treatment of HIV infection. It is also being studied in healthy participants for drug interaction trials. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
The molecular target of MK-4646 has not been disclosed in available information. The drug is being studied for its effects in HIV infection, but its specific mechanism of action is not publicly detailed. It is a small molecule modality under investigation by Merck.
MK-4646 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in HIV-infected participants and healthy volunteers.
MK-4646 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in early-stage trials to assess safety, tolerability, and drug interactions in both HIV-infected participants and healthy individuals.
MK-4646 has been studied in three Phase 1 trials. NCT07042945 evaluated multiple doses in participants with HIV-1 and is completed. NCT07199452 studied the drug with rifabutin in healthy participants and is completed. NCT07785830 is a not-yet-recruiting trial evaluating effects on rosuvastatin in healthy participants.
No alternative names for MK-4646 have been disclosed. The drug is identified solely by its code name MK-4646 in clinical trial registries. It is an investigational compound and is not known to be marketed under any other brand name.