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

Completed · Phase 1

Conditions studied: Renal Insufficiency, Kidney Diseases

In brief

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.

Key facts

Study ID

NCT05624723

Run by

Incyte Corporation

People needed

43

Starts

2023-01-12

Expected to finish

2024-02-07

Last updated by the study team

2024-02-13

Who can join

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

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).
• 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.
• Eligible for Group 1 and have a history of using tobacco- or nicotine-containing products within 6 months of screening.
• Eligible for Groups 2 through 5 and 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 test) at screening or check-in that are not otherwise explained by permitted concomitant medications.
• Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with another investigational medication or current enrollment in another investigational drug study.
• Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose of study drug with moderate and potent inducers or inhibitors of CYP3A4 (refer to the Drug Interaction Database Program [University of Washington School of Pharmacy 2002] for prohibited drugs).
• Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
• Eligible for Group 1 and have used prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and hytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional use of acetaminophen and ibuprofen is permitted (see Section 6.6.1).

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Apex Gmbh — Munich, Germany

Full record on ClinicalTrials.gov

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