This study is conducted to evaluate the pharmacokinetics and safety of INCB161734 in participants with impaired renal function and participants on hemodialysis.
Ability to comprehend and willingness to sign a written ICF for the study.
Aged 18 to 85 years, inclusive, at the time of signing the ICF.
Severe renal impairment or ESRD based on CKD-EPI (National Kidney Foundation).
Medical findings consistent with the degree of renal dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
History of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, or neurological disease within 6 months before screening.
Recent myocardial infarction (within 6 months before check-in).
New York Heart Association Class III or IV congestive heart failure.
Unstable angina (within 6 months before check-in).
Parallel
INCB161734
Drugsingle dose administered orally
PK for plasma INCB161734: Cmax
Defined as the maximum plasma concentration.
PK for plasma INCB161734: AUClast
Defined as the area under the concentration-time curve from time zero to time of the last quantifiable concentration.
PK for plasma INCB161734: AUCinf
Defined as the area under concentration-time curve from time zero extrapolated to infinity.
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after first dose of study drug.
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This trial is not recruiting at the moment. You can still explore other options:
