Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02174159 | Evaluation of Safety, Tolerability, Pharmacokinetics, and Antiretroviral Activity of Ulonivirine (MK-8507) in Human Immunodeficiency Virus (HIV-1)-Infected Participants (MK-8507-003) | PHASE1 | COMPLETED | 18 | — | — | Sep 15, 2014 | Jul 23, 2015 | Apr 10, 2023 | - | — |
| Arm | Type | Description |
|---|---|---|
| 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 | MK-8507 administered as a single oral dose |
Inclusion Criteria: * Male, or non-pregnant and non-breastfeeding female, or postmenopausal or surgically sterile female (confirmed with medical records, examination, or laboratory test). Male participants with female partner of childbearing potential agrees to use a medically acceptable method of ...