A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
Summary
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.
Arms & interventions
- DrugINCB123667
single dose administered orally
Outcome measures
Primary
PK for plasma INCB123667: Cmax
Defined as the maximum plasma concentration.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUCt
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
Time frame: Up to approximately 2 months
PK for plasma INCB123667: AUC∞
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
Time frame: Up to approximately 2 months
Secondary
Number of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 2.5 months
Eligibility criteria
Study locations (4)
Arizona Clinical Trials - the Institute For Liver Health
Chandler, Arizona, 85225
Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute - American Research Corporation
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229