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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Arizona Clinical Trials - the Institute For Liver Health
Chandler, Arizona 85225

Orlando Clinical Research Center
Orlando, Florida 32809

Texas Liver Institute - American Research Corporation
San Antonio, Texas 78215

Pinnacle Clinical Research
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.