Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB000631 When Administered Orally to Healthy Adult Participants
← catalyst calendarSponsored by Incyte Corporation (industry) · INCY — their whole pipeline →.
Phase
Phase 1
Status
Terminated
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
24actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Strategic Business Decision
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-28 | actual | When the study began enrolling |
| Primary completion | 2025-10-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-10-11 | actual | The whole study's end, after follow-up |
| First posted | 2025-06-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: INCB000631
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Treatment-emergent Adverse Events (TEAEs)
measured Up to 2.5 months
PK for plasma INCB000631: Cmax
measured Up to Day 18
PK for plasma INCB000631: tmax
measured Up to Day 18
PK for plasma INCB000631: AUC(0-12)
measured Up to Day 18
PK for plasma INCB000631: AUC(0-24)
measured Up to Day 18
PK for plasma INCB000631: Ctrough
measured Up to Day 18
PK for plasma INCB000631: AUCτ
measured Up to Day 18
PK for plasma INCB000631: AUC∞
measured Up to Day 18
PK for plasma INCB000631: AUClast
measured Up to Day 18
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