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A Study of INCB123667 for Liver Impairment

This study is looking at the safety and how the body handles a drug called INCB123667 when given by mouth to adults with moderate or severe hepatic impairment (liver problems). Researchers want to understand how much of the drug gets into the bloodstream and how long it stays there. You might be able to join if you are an adult between 18 and 80 years old and have moderate or severe liver impairment based on your Child-Pugh (CP) score. The study aims to enroll 16 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 16 participants. It will assess the safety and pharmacokinetics of a single oral dose of INCB123667.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for the drug in your body will be taken for up to approximately 2 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07559474

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Incyte Corporation
~16 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:INCB123667

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PK for plasma INCB123667: Cmax
Measured over Up to approximately 2 months
+2 more outcomes measured

Conditions

Hepatic Insufficiency
Liver Diseases

Explore related trials

Liver Failure

Where it's being run

4 sites across 3 states
Texas2
Arizona1
Florida1

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • PK for plasma INCB123667: CmaxUp to approximately 2 months

    Defined as the maximum plasma concentration.

  • PK for plasma INCB123667: AUCtUp to approximately 2 months

    Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.

  • PK for plasma INCB123667: AUC∞Up to approximately 2 months

    Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.