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

NCT07559474 | Recruiting Phase 1 FDA Drug

• 1 other identifier: INCB123667-104
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

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

Keywords

hepatic impairment; liver impairment (moderate and severe)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Treatment-Emergent Adverse Events (TEAEs)

  Up to approximately 2.5 months

Study Arms (2)

Cohort 1: Moderate hepatic function

EXPERIMENTAL

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

Drug: INCB123667

Cohort 2: Severe hepatic function

EXPERIMENTAL

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

Drug: INCB123667

Interventions

INCB123667 DRUG

single dose administered orally

Cohort 1: Moderate hepatic function; Cohort 2: Severe hepatic function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

Arizona Clinical Trials - the Institute For Liver Health

Chandler, Arizona, 85225, United States

RECRUITING

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

RECRUITING

Texas Liver Institute - American Research Corporation

San Antonio, Texas, 78215, United States

RECRUITING

Pinnacle Clinical Research

San Antonio, Texas, 78229, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hepatic Insufficiency; Liver Diseases; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Incyte Medical Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463; medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423; eumedinfo@incyte.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): April 13, 2027
• Study Completion (Estimated): April 13, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)