Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCB000631 · 1 trial · 1 indication
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 ...
INCB000631 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, and its purpose in this early-stage study is to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and the effect of food when administered orally.
INCB000631 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy adult participants.
INCB000631 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety, tolerability, and other characteristics in healthy participants.
INCB000631 has one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT06775327. This study, titled "Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants," enrolled 71 participants in the United States.
INCB000631 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy participants was designed to gather early safety and tolerability data, and the drug has not yet been evaluated in patient populations for any specific disease.