A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

  • STATUS
    Recruiting
  • End date
    Nov 23, 2023
  • participants needed
    30
  • sponsor
    Incyte Corporation
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Updated on 22 November 2022
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Accepts healthy volunteers

Summary

This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment.

Details
Condition Renal Insufficiency, Kidney Diseases
Treatment INCB054707
Clinical Study IdentifierNCT05624710
SponsorIncyte Corporation
Last Modified on22 November 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different
If the hepatic function classification for the participant is not similar at the 2
timepoints, enrollment of the participant into a hepatic category group will be at the
discretion of the investigator, in consultation with the sponsor's medical monitor. The
enrollment group will be based on the results at screening
Participants eligible for Group 4 (normal hepatic function) should be in good health
as determined by no clinically significant findings in the medical history, physical
examination, vital signs, 12-lead ECGs, or laboratory examinations at screening or
check-in
Participants eligible for Groups 1 through 3 may have medical findings consistent with
their degree of hepatic dysfunction, as determined by medical history, physical
examination, vital signs, 12-lead ECGs, and clinical laboratory examinations at
screening and check-in. Participants with abnormal findings considered not clinically
significant by the investigator are eligible
BMI within the range of 18.0 to 44.0 kg/m2 (inclusive) at screening
Willingness to avoid pregnancy or fathering children

Exclusion Criteria

the opinion of the principal investigator, history of uncontrolled or unstable
cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or
neurological disease within 6 months of screening or evidence of rapidly deteriorating
hepatic function
Serum corrected calcium and phosphorus levels over the upper limits of the
institutional normal ranges
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
A current, functioning organ transplant or a scheduled organ transplant in the next 6
weeks from 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
Severe ascites (ascites requiring paracentesis more than every 4 weeks) or an
encephalopathy ≥ Grade 2 (precludes them from understanding and signing an informed
consent)
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 check-in
Current or recent history (within 30 days before screening) of a clinically
significant bacterial, fungal, parasitic, or mycobacterial infection, or currently
receiving systemic antibiotics or current clinically significant viral infection at
screening or check-in
Positive serology for HBV (eg, HBsAg) or HIV. Participants whose results are
compatible with immunity due to infection or prior immunization for HBV may be
included at the discretion of the investigator
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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