Safety and how the drug behaves in adults with moderate to severe liver impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study evaluating oral INCB123667 in adults with hepatic impairment. The main focus is to characterize safety and pharmacokinetics, including how the drug is absorbed, distributed, metabolized, and excreted in this population. Eligible participants are 18 to 80 years old with documented moderate or severe hepatic impairment and a BMI between 18.0 and 43.0 kg/m2. The study is conducted at several U.S. sites under Incyte Corporation in collaboration with local liver health centers.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Everolimus-based calcineurin-free immunosuppression one year after liver transplant

  This trial tests whether switching to or using everolimus with reduced calcineurin inhibitors after year one post-liver transplant can protect kidney function while maintaining graft health in adults at low rejection risk.

  Recruiting Phase 3 Hannover Medical School · Heidelberg, Baden-Wurttemberg and 15 other locations · NCT07739914

• Metastatic liver cancer patient registry from multiple Chinese centers

  This is a registry that collects real-world data on adults with liver metastases to understand patterns and prognosis and to support future research.

  Recruiting at 2 sites Anhui Provincial Hospital · Bengbu, Anhui and 2 other locations · NCT07602504

• Eloralintide in people with and without liver damage

  This Phase 1 study will test how the medicine eloralintide (LY3841136) is absorbed, processed, and tolerated in adults with healthy livers and in those with mild, moderate, or severe liver damage.

  Recruiting at 3 sites Phase 1 Eli Lilly and Company · Orlando, Florida and 2 other locations · NCT07401862

• Single-probe FibroScan for measuring liver stiffness

  This project will try a single-probe FibroScan to measure liver stiffness in adults with chronic liver disease and compare its results to the standard M and XL probes.

  Recruiting Echosens · Besançon and 3 other locations · NCT07400289

• Diagnosing lymphohistiocytic hemophagocytosis in intensive care patients with liver disease

  This study will test whether the HScore can accurately detect lymphohistiocytic hemophagocytosis in adults with hepatocellular insufficiency or cirrhosis admitted to intensive care.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07343037

• How LY3537031 is processed and tolerated in people with normal or impaired liver function

  This trial will test how LY3537031 is absorbed, distributed, and cleared and whether it is safe when given under the skin to adults with normal liver function and to adults with mild, moderate, or severe liver impairment.

  Recruiting at 3 sites Phase 1 Eli Lilly and Company · Kistarcsa and 2 other locations · NCT07165002

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.