This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with moderate or severe hepatic impairment.
Ability to comprehend and willingness to sign a written ICF for the study.
Aged 18 to 80 years, inclusive, at the time of signing the ICF.
Moderate or severe hepatic impairment based on CP score.
Medical findings consistent with the degree of hepatic 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.
Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.
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.
Participants who have a history of paracentesis within 2 months prior to check-in.
Parallel
INCB123667
Drugsingle dose 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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