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

Completed · Phase 1

Conditions studied: Renal Impairment, Hemodialysis

In brief

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.

Key facts

Study ID

NCT05099445

Run by

Incyte Corporation

People needed

48

Starts

2021-12-14

Expected to finish

2023-02-27

Last updated by the study team

2023-05-15

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: accepted.

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.
• 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).
• Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
• Positive test and symptomatic for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
• Participants eligible for Group 1 who have a history of using tobacco- or nicotine containing products within 6 months of screening.
• Participants eligible for Groups 2 through 5 who smoke > 10 cigarettes per day or equivalent use of other tobacco- or nicotine-containing products and are unwilling to refrain from tobacco or nicotine use on dosing days and abide by CRU restrictions.
• History of alcohol dependency within 3 months of screening.
• Positive breath test for ethanol or positive urine or saliva screen for drugs of abuse (confirmed by repeat) at screening or check-in that are not otherwise explained by permitted concomitant medications.

Where it is running

• Inland Empire Liver Foundation — Rialto, California, United States
• Clinical Pharmacology of Miami — Hialeah, Florida, United States
• Advanced Pharma — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Nucleus Network Minneapolis Clinic — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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