Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
71actual
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
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-13 | actual | When the study began enrolling |
| Primary completion | 2025-05-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-28 | actual | The whole study's end, after follow-up |
| First posted | 2025-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-06-11 | 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 Day 41
PK for plasma INCB000631: Cmax
measured Up to Day 14
PK for plasma INCB000631: tmax
measured Up to Day 14
PK for plasma INCB000631: AUC(0-t)
measured Up to Day 14
PK for plasma INCB000631: AUC 0-∞
measured Up to Day 14
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