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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05324410 | A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants | PHASE1 | COMPLETED | 88 | — | — | Apr 7, 2022 | Nov 7, 2022 | Dec 8, 2022 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A: VX-840 | EXPERIMENTAL | Participants will be randomized to receive single dose of one of different dose levels of VX-840. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to VX-840. |
| Part B: VX-840 | EXPERIMENTAL | Participants will be randomized to receive multiple doses of one of different dose levels of VX-840. The dose levels will be determined based on the data from Part A. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to VX-840. |
| Name | Type | Description |
|---|---|---|
| VX-840 | DRUG | Solution for oral administration. |
| Placebo | DRUG | Placebo matched to VX-840 for oral administration. |
Key Inclusion Criteria: * Female participants must be of non-childbearing potential * Body mass index (BMI) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * A total body weight greater than (\>) 50 kg Key Exclusion Criteria: * History of febrile illness or other acute illness within 14 days...