Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

NCT05624723 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB054707-106
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a multi-center, open-label, parallel-group study to evaluate oral doses of 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 INCB054707

  Defined as maximum observed plasma concentration of INCB054707

  Days 1-4

• Pharmacokinetics Parameter: AUC0-t of INCB054707

  Area Under the concentration- time curve up to the last measurable concentration of INCB054707

  Days 1-4

• Pharmacokinetics Parameter: AUC0-∞ of INCB54707

  Defined as under the concentration-time curve up to the last measurable concentration of INCB054707

  Days 1-4

Secondary Outcomes (6)

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

  Up to 21 days

• Pharmacokinetics Parameter: tmax of INCB054707

  Days 1-4

• Pharmacokinetics Parameter: t½ of INCB054707

  Days 1-4

• Pharmacokinetics Parameter: CL/F of INCB054707

  Days 1-4

• Pharmacokinetics Parameter: Vz/F of INCB054707

  Days 1-4

Study Arms (5)

Group 1: Normal Renal Function

EXPERIMENTAL

Participants with normal levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.

Drug: INCB054707

Group 2: Mild Renal Impairment

EXPERIMENTAL

Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.

Drug: INCB054707

Group 3: Moderate Renal Impairment

EXPERIMENTAL

Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.

Drug: INCB054707

Group 4: Severe Renal Impairment

EXPERIMENTAL

Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.

Drug: INCB054707

Group 5: Kidney Failure

EXPERIMENTAL

Group 5 participants with ESRD maintained on HD will receive a single dose of INCB054707 across 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB054707.

Drug: INCB054707

Interventions

INCB054707 DRUG

INCB054707 75 mg will be administered orally

Also known as: Povorcitinib

Group 1: Normal Renal Function; Group 2: Mild Renal Impairment; Group 3: Moderate Renal Impairment; Group 4: Severe Renal Impairment; Group 5: Kidney Failure

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classification at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
• Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
• Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
• Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations at screening and Day -1 (Groups 2 through 4) or Period 1 Day -1 (Group 5).
• Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening.
• Willingness to avoid pregnancy or fathering children

You may not qualify if:

• History of uncontrolled or unstable cardiovascular, respiratory, hepatic, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating renal function.
• Current, functioning organ transplant or a cheduled organ transplant within 6 weeks after 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.
• Eligible for Group 1 and have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.
• Eligible for Groups 2 through 5 and have had a change in disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the investigator.
• 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
• 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 Day -1 (for Groups 1 through 4) or Period 1 Day -1 (Group 5).

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, 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
• 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: January 12, 2023
• Primary Completion: February 7, 2024
• Study Completion: February 7, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (1)