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NCT Number: NCT07559474

A 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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arizona Clinical Trials - the Institute For Liver Health, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INCB123667

Drug

single dose administered orally

Primary outcomes

  1. PK for plasma INCB123667: Cmax

    Time frame: Up to approximately 2 months

    Defined as the maximum plasma concentration.

  2. PK for plasma INCB123667: AUCt

    Time frame: Up to approximately 2 months

    Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.

  3. PK for plasma INCB123667: AUC∞

    Time frame: Up to approximately 2 months

    Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.

Secondary outcomes

  1. Number of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 2.5 months

    Adverse events reported for the first time or worsening of a pre-existing event, occurring after study drug/treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 30, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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