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
Incyte Corporation
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * Body…
Interventions
- DrugINCB123667
single dose administered orally
Locations (4)
- Arizona Clinical Trials - the Institute For Liver HealthChandler, Arizona
- Orlando Clinical Research CenterOrlando, Florida
- Texas Liver Institute - American Research CorporationSan Antonio, Texas
- Pinnacle Clinical ResearchSan Antonio, Texas