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

A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Diseases; Hepatic Insufficiency
• Intervention / Treatment: Drug: INCB123667

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Moderate hepatic function; Participants with moderate hepatic impairment will be enrolled in Cohort 1.	Drug: INCB123667; single dose administered orally
Experimental: Cohort 2: Severe hepatic function; Participants with severe hepatic impairment will be enrolled in Cohort 2.	Drug: INCB123667; single dose administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK for plasma INCB123667: Cmax	Defined as the maximum plasma concentration.	Up to approximately 2 months
PK for plasma INCB123667: AUCt	Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.	Up to approximately 2 months
PK for plasma INCB123667: AUC∞	Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.	Up to approximately 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment-Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.	Up to approximately 2.5 months

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Incyte Medical Monitor, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): April 13, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hepatic impairment; liver impairment (moderate and severe)
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Digestive System Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Liver Diseases; Lymphoma, Follicular; Hepatic Insufficiency
• Other Study ID Numbers: INCB123667-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No