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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06941077 | A Study to Evaluate the Relative Bioavailability of New Formulations of INCB057643 Tablets Administered Orally in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | May 12, 2025 | Jun 3, 2025 | Jun 11, 2025 | 1 | United States |
Defined as maximum observed plasma concentration of INCB057643.
Defined as area under the single-dose serum concentration-time curve from time = 0 to the last measurable concentration at time of INCB057643.
Defined as the area under the single-dose serum concentration-time curve extrapolated to time of infinity of INCB057643.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose Treatment A | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 3: Dose Treatment C | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment D | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Cohort 4: Dose Treatment E | EXPERIMENTAL | INCB057643 will be administered at protocol defined dose. |
| Name | Type | Description |
|---|---|---|
| INCB057643 | DRUG | Tablet |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Aged 18 to 55 years, inclusive, at the time of signing the ICF. * BMI within the range of 18.0 to 30.0 kg/m2 inclusive. Note: Up to 25% of the participants in each cohort may be enrolled with a BMI \>...