Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C]Ulonivirine, MK-8507, ULO
Ulonivirine · 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...
Ulonivirine is an investigational small molecule being studied for the treatment of HIV-1 infection. It is also being evaluated in people with mild or moderate hepatic impairment. It has not been approved for any indication and remains in Phase 1 clinical development.
Ulonivirine is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program for the drug, including the Phase 1 studies in HIV-1 infection and in hepatic insufficiency.
Ulonivirine is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The program includes one completed Phase 1 trial and one Phase 1 trial in hepatic impairment.
Ulonivirine has been studied in two Phase 1 trials. NCT02174159 evaluated safety, tolerability, pharmacokinetics, and antiretroviral activity in HIV-1 infected participants and is completed. NCT05093972 is evaluating Ulonivirine in participants with mild or moderate hepatic impairment.
Yes, [14C]Ulonivirine is an alternative name for Ulonivirine. The carbon-14 labeled form is used in study work, and both names refer to the same investigational compound being developed by Merck for HIV-1 infection and hepatic insufficiency.
Across the Ulonivirine clinical program, 22 participants are planned or enrolled in the hepatic impairment study, and 18 participants were enrolled in the completed HIV-1 study. The trials are Phase 1 and include adult participants aged 18 years and older.