Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ulonivirine · 6 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.
The AUC0-24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
The AUC0-24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
Blood samples will be collected at multiple time points to determine the AUC0-inf of atorvastatin
Blood samples will be collected at multiple time points to determine the AUC0-inf of metformin
Change from baseline in QTc following ulonivirine administration will be reported.
Blood samples will be collected to determine the Cqtc of ulonivirine.
Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.
Urine samples will be collected to determine the percent of total radioactivity recovered from urine.
Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.
Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.
Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.
Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.
Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.
Plasma samples will be collected to determine the AUC0-last of ulonivirine.
Plasma samples will be collected to determine the AUC0-inf of ulonivirine.
Plasma samples will be collected to determine the Cmax of ulonivirine.
Plasma samples will be collected to determine the C168 of ulonivirine.
Plasma samples will be collected to determine the t1/2 of ulonivirine.
Plasma samples will be collected to determine the Tmax of ulonivirine.
Plasma samples will be collected to determine the ratio of ulonivirine to total plasma radioactivity: AUC0-last (ulonivirine)/ AUC0-last (total radioactivity)
Plasma samples will be collected to determine the AUC0-last of total radioactivity.
Plasma samples will be collected to determine the AUC0-inf of total radioactivity.
Plasma samples will be collected to determine the Cmax of total radioactivity.
Plasma samples will be collected to determine the C168 of total radioactivity.
Plasma samples will be collected to determine the t1/2 of total radioactivity.
Plasma samples will be collected to determine the Tmax of total radioactivity.
Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.
| 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. |
| Methadone + Ulonivirine | EXPERIMENTAL | Participants receive a stable dose of methadone orally from Day -14 through Day 16. Methadone is co-administered with one dose of oral ulonivirine on Day 2. |
| Atorvastatin + metformin + ulonivirine | EXPERIMENTAL | In Period 1, participants will receive atorvastatin and metformin. In Period 2, participants will receive atorvastatin, metformin, and ulonivirine. |
| 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. |
| [14C]Ulonivirine | EXPERIMENTAL | All participants receive a single oral dose of \[14C\]ulonivirine on Day 1. |
| 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. |
| Methadone | DRUG | Oral (per local guidelines) |
| Atorvastatin | DRUG | Oral tablet |
| Metformin | DRUG | Oral tablet |
| Moxifloxacin | DRUG | Oral tablet |
| Ulonivirine Placebo | DRUG | Oral tablet |
| Moxifloxacin Placebo | DRUG | Oral tablet |
| [14C]Ulonivirine | DRUG | Oral Solution |
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...
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Ulonivirine is an investigational small molecule being studied for use in HIV-1 infection, as well as in healthy volunteers and people with hepatic insufficiency. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
Ulonivirine is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The drug is in Phase 1 clinical trials for infectious disease indications.
Ulonivirine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being evaluated in early-stage clinical trials for safety and other characteristics.
Ulonivirine has four clinical trials listed on ClinicalTrials.gov. Three are completed: NCT07305831, a heart rhythm study in healthy adults; NCT07334886, a radiolabeled study in healthy males; and NCT07530289, a drug interaction study with atorvastatin and metformin. One trial, NCT07595263, is not yet recruiting and will study Ulonivirine with methadone in healthy volunteers.
Yes, Ulonivirine is also known as MK-8507. Clinical trial records refer to the drug by both names, such as in the study titles for NCT07305831 and NCT07334886, which list Ulonivirine (MK-8507).