A Phase 1 interventional study of INCB054707 in Renal Insufficiency and Kidney Diseases, sponsored by Incyte Corporation. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 25 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.
Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
- Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different.
If the hepatic function classification for the participant is not similar at the 2 timepoints, enrollment of the participant into a hepatic category group will be at the discretion of the investigator, in consultation with the sponsor's medical monitor. The enrollment group will be based on the results at screening.
Exclusion Criteria:
History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Drug: INCB054707
Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Drug: INCB054707
Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Drug: INCB054707
Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1.
Drug: INCB054707
INCB054707 75 mg will be administered orally on Day 1.
Also known as: Povorcitinib
Pharmacokinetics Parameter: Cmax of INCBC054707
Defined as maximum observed plasma concentration of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.
Time frame: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Defined as area under the concentration-time curve From 0 to Infinity of INCB054707
Time frame: Days 1 - 5
Number of Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Time frame: up to 15 days
Pharmacokinetics Parameter: tmax of INCB054707
Defined as time to reach maximum plasma concentration of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: t1/2 0f INCB054707
Defined as apparent terminal phase disposition half-life of INCB54707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: CL/F of INCB054707
Defined as oral dose clearance of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter:: Vz/F of INCB054707
Defined as apparent oral dose volume of distribution of INCB054707
Time frame: Days 1 - 5
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Incyte Corporation