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Recruiting NCT07559474

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

Phase I Interventional Hepatic Insufficiency Liver Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INCB123667.
Who it may be relevant to
Registry conditions: Hepatic Insufficiency, Liver Diseases. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug INCB123667
    single dose administered orally

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Number of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 2.5 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Arizona Clinical Trials - the Institute For Liver Health — Chandler
  • Orlando Clinical Research Center — Orlando
  • Texas Liver Institute - American Research Corporation — San Antonio
  • Pinnacle Clinical Research — San Antonio

Identifiers

NCT: NCT07559474 · INCB123667-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗