Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB057643 · 2 trials · 8 indications
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.
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with ruxolitinib.
| 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. |
| Part 1 : INCB057643 Monotherapy | EXPERIMENTAL | INCB057643 dose escalation and dose expansion |
| Part 2 : INCB057643 Combination with Ruxolitinib | EXPERIMENTAL | Combination arm in dose escalation and dose expansion |
| Name | Type | Description |
|---|---|---|
| INCB057643 | DRUG | Tablet |
| Ruxolitinib | DRUG | Ruxolitinib will be administered twice a day using the dose described for each Cohort in the protocol for Part 2. |
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 \>...