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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06555081 | A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants | PHASE1 | COMPLETED | 168 | — | — | Sep 25, 2024 | Nov 7, 2024 | Feb 13, 2025 | 1 | United States |
| NCT06310304 | A Study to Evaluate the Relative Bioavailability of Ruxolitinib Extended Release (XR) Tablets Compared With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants. | PHASE1 | COMPLETED | 24 | — | — | Mar 26, 2024 | May 15, 2024 | Jun 5, 2024 | 1 | United States |
INCB018424 concentration in plasma.
| Arm | Type | Description |
|---|---|---|
| Period 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Period 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Name | Type | Description |
|---|---|---|
| Ruxolitinib IR | DRUG | Tablet |
| Ruxolitinib XR | DRUG | Tablet |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Healthy adult participants aged 18 to 55 years, inclusive at screening. * Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled...