Recruiting
Phase 1

INCB123667

Sponsor:

Incyte Corporation

Code:

NCT07559474

Conditions

Hepatic Insufficiency

Liver Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

INCB123667

Study Details

Brief 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.

Conditions

Hepatic Insufficiency

Liver Diseases

Study ID

NCT07559474

Start date

May 27, 2026

Status verified date

Jun, 2026

Completion date

Apr 13, 2027

Anticipated

Primary completion date

Apr 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Moderate hepatic function

Participants with moderate hepatic impairment will be enrolled in Cohort 1.

experimental: Cohort 2: Severe hepatic function

Participants with severe hepatic impairment will be enrolled in Cohort 2.

Interventions

INCB123667

single dose administered orally

Primary outcome measure

  • PK for plasma INCB123667: Cmax [ Time Frame: Up to approximately 2 months ]
  • PK for plasma INCB123667: AUCt [ Time Frame: Up to approximately 2 months ]
  • PK for plasma INCB123667: AUC∞ [ Time Frame: Up to approximately 2 months ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

Arizona Clinical Trials - the Institute For Liver Health

Recruiting

Chandler, Arizona, United States, 85225

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

Texas Liver Institute - American Research Corporation

Recruiting

San Antonio, Texas, United States, 78215

Pinnacle Clinical Research

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Incyte Corporation

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • hepatic impairment
  • liver impairment (moderate and severe)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-06-16.