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Clinical Trials in the USA / NCT07559474
Recruiting Phase 1

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

NCT07559474 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 1
Started
2026-05-27
Last updated
2026-06-16

Condition(s) studied

Hepatic InsufficiencyLiver Diseases

Investigational drug(s) / intervention(s)

INCB123667

INCB123667: single dose administered orally

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
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 mass index of 18.0 to 43.0 kg/m2 (inclusive). * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * 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. * Participants who required new medication or an increase in dose for hepatic encephalopathy within 3 months prior to check-in. * Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor. Participants who have a portal systemic shunt. Up to 3 participants with transjugular intrahepatic portosystemic shunt may be included. * Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Arizona Clinical Trials - the Institute For Liver Health Chandler Arizona Recruiting
Orlando Clinical Research Center Orlando Florida Recruiting
Texas Liver Institute - American Research Corporation San Antonio Texas Recruiting
Pinnacle Clinical Research San Antonio Texas Recruiting

More Incyte Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07559474 on ClinicalTrials.gov ↗ ← All trials in the USA