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

NCT05624710 | Completed Phase 1 FDA Drug

• 2 other identifiers: INCB 54707-1052022-002660-70
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Renal Insufficiency; Kidney Diseases

Keywords

renal impairment; hemodialysis; Kidney failure; end-stage renal disease

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics Parameter: Cmax of INCBC054707

  Defined as maximum observed plasma concentration of INCB054707

  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.

  Days 1 - 5

• Pharmacokinetics Parameter: AUC(0-∞) of INCB054707

  Defined as area under the concentration-time curve From 0 to Infinity of INCB054707

  Days 1 - 5

Secondary Outcomes (5)

• Number of Treatment Emergent Adverse Events (TEAE'S)

  up to 15 days

• Pharmacokinetics Parameter: tmax of INCB054707

  Days 1 - 5

• Pharmacokinetics Parameter: t1/2 0f INCB054707

  Days 1 - 5

• Pharmacokinetics Parameter: CL/F of INCB054707

  Days 1 - 5

• Pharmacokinetics Parameter:: Vz/F of INCB054707

  Days 1 - 5

Study Arms (4)

Group 1: Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: INCB054707

Group 2: Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: INCB054707

Group 3: Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: INCB054707

Group D: Normal Hepatic Function

EXPERIMENTAL

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

Drug: INCB054707

Interventions

INCB054707 DRUG

INCB054707 75 mg will be administered orally on Day 1.

Also known as: Povorcitinib

Group 1: Severe Hepatic Impairment; Group 2: Moderate Hepatic Impairment; Group 3: Mild Hepatic Impairment; Group D: Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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:
• Recent myocardial infarction (within 6 months of check-in).
• New York Heart Association Class III or IV congestive heart failure.
• Unstable angina (within 6 months of check-in).
• Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Orange County Research Center

Tustin, California, 92780, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office

San Antonio, Texas, 78215, United States

Location

Apex Gmbh

Munich, D-81241, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 22, 2022
• Study Start: December 8, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (1)