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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06775327 | Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants | PHASE1 | COMPLETED | 71 | — | — | Feb 13, 2025 | May 28, 2025 | Jun 11, 2025 | 1 | United States |
Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after dose of study treatment.
Maximum Observed Plasma Concentration of INCB000631.
Time to maximum plasma concentration of INCB000631.
Area under the single-dose plasma concentration-time curve up to the last measurable plasma concentration of INCB000631.
Area under the single-dose plasma concentration-time curve from 0 to Infinity of INCB000631.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort B | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort C | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort D | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort E | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Optional Cohort F | EXPERIMENTAL | INCB000631 or placebo will be administered at the protocol defined dose. |
| Cohort G Treatment A | EXPERIMENTAL | INCB000631 will be administered at the protocol defined dose. |
| Cohort G Treatment B | EXPERIMENTAL | INCB000631 will be administered at the protocol defined dose. |
| Name | Type | Description |
|---|---|---|
| INCB000631 | DRUG | Oral; Tablet |
| Placebo | DRUG | Oral; Tablet |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Aged 19 to 55 years, inclusive, at the time of signing the ICF. * 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 with a ...