Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ulonivirine, ULO
MK-8507 · 3 trials · 3 indications
The AUC0-∞ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The AUC0-last of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The Cmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The Tmax of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The t½ of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The CL/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
The Vz/F of ulonivirine will be determined in participants with mild or moderate HI and healthy controls.
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.
Blood samples will be collected to determine Cmax of Islatravir metabolite.
Blood samples will be collected to determine the C168 of Islatravir metabolite.
Blood samples will be collected to determine the Tmax of Islatravir metabolite.
Blood samples will be collected to determine the t1/2 of Islatravir metabolite.
Blood samples will be collected to determine the AUC0-Inf of Islatravir.
Blood samples will be collected to determine the AUC0-168hrs of Islatravir.
Blood samples will be collected to determine Cmax of Islatravir.
Blood samples will be collected to determine the C168 of Islatravir.
Blood samples will be collected to determine the Tmax of Islatravir.
Blood samples will be collected to determine the t1/2 of Islatravir.
Blood samples will be collected to determine the CL/F of Islatravir.
Blood samples will be collected to determine the Vd/F of Islatravir.
Blood samples will be collected to determine the AUC0-168hrs of MK-8507.
Blood samples will be collected to determine Cmax of MK-8507.
Blood samples will be collected to determine the C168 of MK-8507.
Blood samples will be collected to determine the Tmax of MK-8507.
Blood samples will be collected to determine the t1/2 of MK-8507.
Blood samples will be collected to determine the CL/F of MK-8507.
Blood samples will be collected to determine the Vd/F of MK-8507.
| Arm | Type | Description |
|---|---|---|
| Panel A: Mild HI | EXPERIMENTAL | Participants with mild HI receive a single oral dose of ulonivirine 400 mg on Day 1. |
| Panel B: Moderate HI | EXPERIMENTAL | Participants with moderate HI receive a single oral dose of ulonivirine 400 mg on Day 1. |
| Panel C: Healthy Controls | ACTIVE_COMPARATOR | Healthy matched control participants receive a single oral dose of ulonivirine 400 mg on Day 1. |
| Islatravir+MK-8507 | EXPERIMENTAL | Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29. |
| Panel A: Ulonivirine 600 mg | EXPERIMENTAL | Single oral dose of ulonivirine 600 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast |
| Panel B: Ulonivirine 150 mg | EXPERIMENTAL | Single oral dose of ulonivirine 150 mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast |
| Panel C: Ulonivirine <=600 mg | EXPERIMENTAL | Single oral dose of ulonivirine \<=600 mg mg (supplied as 10 mg and 100 mg tablets) administered after an overnight fast. Inclusion of Panel C in the study, and the dose selected, will be decided pending evaluation of results for Panels A and B. |
| Name | Type | Description |
|---|---|---|
| Ulonivirine | DRUG | Four ulonivirine 100 mg tablets (total dose 400 mg) taken by mouth. |
| MK-8507 | DRUG | Oral administration |
| Islatravir | DRUG | Oral administration |
Inclusion Criteria: Mild and Moderate HI (Panels A and B): * Has a diagnosis of chronic (\>6 months), stable HI with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepati...
MK-8507 is an investigational small molecule developed by Merck & Company, Inc. (ticker MRK). It has been studied in a Phase 1 clinical trial in healthy adult participants, including a study combining it with islatravir (MK-8591). Its specific therapeutic indication has not been publicly disclosed.
MK-8507 is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck sponsored the Phase 1 study of MK-8507, including the trial evaluating it alongside islatravir (MK-8591) in healthy adult participants.
MK-8507 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study enrolled 36 healthy adult participants in the United States. MK-8507 is investigational and has not been approved by the FDA.
MK-8507 has been evaluated in the Phase 1 trial NCT06619678, titled "A Study of MK-8507 and Islatravir (MK-8591) in Healthy Adult Participants (MK-8507-016)." The trial enrolled 36 healthy volunteers aged 19 years and older in the United States and is now completed.
No. MK-8507 and islatravir (also called MK-8591) are separate compounds. The two were studied together in the Phase 1 trial NCT06619678, which evaluated MK-8507 and islatravir in healthy adult participants. Both are associated with Merck & Company, Inc. (ticker MRK).