A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIncyte Corporation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • INCB123667

Treatment groups

16 Participants
are divided into 2 treatment groups

Locations

4
Arizona Clinical Trials - the Institute For Liver Health85225, ChandlerArizona, United States
Orlando Clinical Research Center32809, OrlandoFlorida, United States
Pinnacle Clinical Research78229, San AntonioTexas, United States
Texas Liver Institute - American Research Corporation78215, San AntonioTexas, United States

Sponsors and collaborators

Incyte Corporation

Lead sponsor