Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

NCT05099445 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 00928-108
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief Summary

This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.

Conditions

Renal Impairment; Hemodialysis

Keywords

renal impairment; hemodialysis; Kidney failure; end-stage renal disease; Fibrodysplasia ossificans progressiva

Outcome Measures

Primary Outcomes (3)

• PK for plasma of INCB000928: Cmax

  Defined as maximum observed plasma or serum concentration, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928

  Days 1 - 4

• PK for plasma of INCB000928: AUC0-t

  Defined as area under the steady-state plasma or serum concentration-time curve over 1 dose interval, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.

  Days 1 - 4

• PK for plasma of INCB000928: AUC0-∞

  Defined as area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.

  Days 1 - 4

Secondary Outcomes (6)

• Number of treatment-related adverse events

  Days 1-4 and follow up; up to 14 days

• PK for plasma of INCB000928: tmax

  Days 1 - 4

• PK for plasma of INCB000928: t½

  Days 1 - 4

• PK for plasma of INCB000928: CL/F

  Days 1 - 4

• PK for plasma of INCB000928: Vz/F

  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 INCB000928 200 mg on Day 1.

Drug: INCB000928

Group 2: Mild Renal Impairment

EXPERIMENTAL

Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.

Drug: INCB000928

Group 3: Moderate Renal Impairment

EXPERIMENTAL

Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.

Drug: INCB000928

Group 4: Severe Renal Impairment

EXPERIMENTAL

Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.

Drug: INCB000928

Group 5: Kidney Failure

EXPERIMENTAL

Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928.

Drug: INCB000928

Interventions

INCB000928 DRUG

INCB000928 200 mg will be administered on Day 1 of each treatment period.

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:

• Age 18 to 82 years (inclusive) at the time of signing the ICF.
• Participants will be classified 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). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
• Body mass index within the range 18.0 to 40.0 kg/m2 (inclusive) at screening.
• Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
• Ability to swallow and retain oral medication.

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.
• Evidence of rapidly deteriorating renal function.
• Participants who have a current, functioning organ transplant or have a scheduled 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.
• Participants eligible for Group 1 who have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.
• Participants eligible for Groups 2 through 5 who 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (5)

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Advanced Pharma

Miami, Florida, 33147, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Nucleus Network Minneapolis Clinic

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Myositis Ossificans

Condition Hierarchy (Ancestors)

Kidney Diseases; 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; Myositis; Muscular Diseases; Musculoskeletal Diseases

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: October 18, 2021
• First Posted: October 29, 2021
• Study Start: December 14, 2021
• Primary Completion: February 19, 2023
• Study Completion: February 27, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (5)