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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06168318 | A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants | PHASE1 | COMPLETED | 46 | — | — | Dec 18, 2023 | Jun 3, 2024 | Aug 2, 2024 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Part 1 - Regimen A | EXPERIMENTAL | VH4004280 Formulation A tablet administered in fed conditions. |
| Part 1 - Regimen B | EXPERIMENTAL | VH4004280 Formulation B tablet administered in fed conditions. |
| Part 1 - Regimen C | EXPERIMENTAL | VH4004280 Formulation C tablet administered in fed conditions. |
| Part 1 - Optional Regimen D | EXPERIMENTAL | VH4004280 Formulation D tablet administered in fed conditions. |
| Part 1 - Optional Regimen E | EXPERIMENTAL | VH4004280 Formulation E tablet administered in fed conditions. |
| Part 2 - Regimen A | EXPERIMENTAL | VH4004280 Formulation A tablet administered in fasted conditions. |
| Part 2- Optional Regimen 1 | EXPERIMENTAL | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 2- Optional Regimen 2 | EXPERIMENTAL | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 2- Optional Regimen 3 | EXPERIMENTAL | VH4004280 Formulation B, C, D, or E tablet administered in fasted conditions. |
| Part 3 - Optional Regimen 1 | EXPERIMENTAL | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3- Optional Regimen 2 | EXPERIMENTAL | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3 - Optional Regimen 3 | EXPERIMENTAL | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Part 3 - Optional Regimen 4 | EXPERIMENTAL | VH4004280 Formulation A, B, C or D tablet administered in lower fat conditions. |
| Name | Type | Description |
|---|---|---|
| VH4004280 Formulation A | DRUG | Oral administration of VH4004280 Formulation A in fasted or fed conditions. |
| VH4004280 Formulation B | DRUG | Oral administration of VH4004280 Formulation B in fasted or fed conditions. |
| VH4004280 Formulation C | DRUG | Oral administration of VH4004280 Formulation C in fasted or fed conditions. |
| VH4004280 Formulation D | DRUG | Oral administration of VH4004280 Formulation D in fasted or fed conditions. |
| VH4004280 Formulation E | DRUG | Oral administration of VH4004280 Formulation E in fasted or fed conditions. |
Inclusion Criteria: 1. Participants must be 18 to 55years of age. 2. Participants who are overtly healthy. 3. Negative (Severe Acute Respiratory Syndrome Coronavirus 2) SARs-CoV-2 test prior to dosing. 4. Has body mass index (BMI) within the range 19-32 (kg/m2). 5. Participants male at birth must u...