This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
Aged 18 to 85 years, inclusive, at the time of signing the ICF.
Severe renal impairment or ESRD based on CKD-EPI.
Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
Willingness to avoid pregnancy or fathering children.
Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.
Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.
Tobacco or nicotine-containing product use of > 10 cigarettes per day within 1 month before screening.
Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.
Parallel
INCB123667
DrugGroup 1: Single dose administered orally. Group 2: Two single doses administered orally.
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
PK for plasma INCB123667: AUCt
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
PK for plasma INCB123667: AUC∞
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
Number of Treatment-Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.
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