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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06368986 | A Study to Investigate the Effect of Food on the Bioavailability of a Capsid Inhibitor (CAI) in Male and Female Healthy Participants | PHASE1 | COMPLETED | 60 | — | — | Apr 17, 2024 | Oct 2, 2024 | Feb 18, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose A - Fasted condition | EXPERIMENTAL | VH4011499 Dose A tablet administered in fasted condition. |
| Part 1 Dose A- Fed condition (high fat meal) | EXPERIMENTAL | VH4011499 Dose A tablet administered in fed condition (high fat meal). |
| Part 2 Dose B - Optional - Fed condition (low fat meal) | EXPERIMENTAL | VH4011499 Dose B tablet administered in fed condition (low fat meal). |
| Part 3 Dose B - Fasted condition | EXPERIMENTAL | VH4011499 Dose B tablet administered in fasted condition. |
| Part 3 Dose B - Fed condition (high fat meal) | EXPERIMENTAL | VH4011499 Dose B tablet administered in fed condition (high fat meal). |
| Name | Type | Description |
|---|---|---|
| VH4011499 Dose A | DRUG | VH4011499 administered in fasted or fed conditions. |
| VH4011499 Dose B | DRUG | VH4011499 Dose B administered in fasted or fed conditions. |
Inclusion Criteria: * Participants who are 18 to 55 years of age. * Participants who are overtly healthy. * One SARs-CoV-2 negative test is required prior to dosing * Body weight within 50-100 kg and body mass index (BMI) within the range 19-32 kg/m2 (inclusive). * Capable of giving signed informed...