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

COMPLETEDPHASE1

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

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

NCT05624723•Incyte Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 82 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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:
•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)
+27 more criteria

Locations (2)

Orlando Clinical Research Center

Orlando, Florida, United States

Apex Gmbh

Munich, Germany

Key Dates

Start Date

January 12, 2023

Primary Completion Date

February 7, 2024

Completion Date

February 7, 2024

Last Updated

February 13, 2024

Enrollment

ACTUAL participants

Conditions

Renal InsufficiencyKidney Diseases

Interventions

INCB054707

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Contrast Medium Sparing Strategy Using Automated CO2 Injection During PVI for Prevention of Major Adverse Kidney Events (MAKE)

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