A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult… (NCT07559474) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment
16 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%). …