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CompletedNCT05624710Updated Aug 3, 2025

A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

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

From the registry’s dates

  • Primary completion was Jun 2023, 3 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.

02

Conditions studied

  • Renal Insufficiency
  • Kidney Diseases

Keywords

  • renal impairment
  • hemodialysis
  • Kidney failure
  • end-stage renal disease
03

In context

Renal Insufficiency

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

- 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.

  • Participants eligible for Group 4 (normal hepatic function) should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECGs, or laboratory examinations at screening or check-in.
  • Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the investigator are eligible.
  • BMI within the range of 18.0 to 44.0 kg/m2 (inclusive) at screening.
  • Willingness to avoid pregnancy or fathering children.

Exclusion criteria

Exclusion Criteria:

  • the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating hepatic function.
  • Serum corrected calcium and phosphorus levels over the upper limits of the institutional normal ranges.
  • 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:

    1. Recent myocardial infarction (within 6 months of check-in).
    2. New York Heart Association Class III or IV congestive heart failure.
    3. Unstable angina (within 6 months of check-in).
    4. Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).
    5. Uncontrolled hypertension.
  • A current, functioning organ transplant or a scheduled organ transplant in the next 6 weeks from check-in.
  • History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
  • History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
  • Severe ascites (ascites requiring paracentesis more than every 4 weeks) or an encephalopathy ≥ Grade 2 (precludes them from understanding and signing an informed consent).
  • Any major surgery within 4 weeks of screening.
  • Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
  • Blood transfusion within 4 weeks of check-in.
  • Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in.
  • Positive serology for HBV (eg, HBsAg) or HIV. Participants whose results are compatible with immunity due to infection or prior immunization for HBV may be included at the discretion of the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Group 1: Severe Hepatic Impairment

    Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.

    Drug: INCB054707

  • Experimental
    Group 2: Moderate Hepatic Impairment

    Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.

    Drug: INCB054707

  • Experimental
    Group 3: Mild Hepatic Impairment

    Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.

    Drug: INCB054707

  • Experimental
    Group D: Normal Hepatic Function

    Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1.

    Drug: INCB054707

Interventions

  • DrugINCB054707

    INCB054707 75 mg will be administered orally on Day 1.

    Also known as: Povorcitinib

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics Parameter: Cmax of INCBC054707

    Defined as maximum observed plasma concentration of INCB054707

    Time frame: Days 1 - 5

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. Pharmacokinetics Parameter: tmax of INCB054707

    Defined as time to reach maximum plasma concentration of INCB054707

    Time frame: Days 1 - 5

  3. Pharmacokinetics Parameter: t1/2 0f INCB054707

    Defined as apparent terminal phase disposition half-life of INCB54707

    Time frame: Days 1 - 5

  4. Pharmacokinetics Parameter: CL/F of INCB054707

    Defined as oral dose clearance of INCB054707

    Time frame: Days 1 - 5

  5. Pharmacokinetics Parameter:: Vz/F of INCB054707

    Defined as apparent oral dose volume of distribution of INCB054707

    Time frame: Days 1 - 5

07

Study locations

4 sites
  • Orange County Research Center
    Tustin, California 92780, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
  • Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
    San Antonio, Texas 78215, United States
  • Apex Gmbh
    Munich, D-81241, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05624710
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Nov 22, 2022
Start date
Dec 8, 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Aug 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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