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 drug being developed by Incyte Corporation. It has been studied in a Phase 1 clinical trial in healthy adult participants, evaluating its safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect. The specific disease indications for which it is being developed have not been disclosed.
INCB000631 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker symbol INCY. Incyte is the sponsor of the clinical program evaluating this small molecule compound.
INCB000631 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
INCB000631 has been evaluated in one clinical trial, NCT06775327, titled a study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of oral INCB000631 in healthy adult participants. The trial was a completed Phase 1 study conducted in the United States with 71 enrolled participants.
The Phase 1 trial NCT06775327 evaluated the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of oral INCB000631 in healthy adult participants. It was a randomized, double-blind, controlled study that enrolled 71 participants aged 19 years and older in the United States.