ClinicalTrials.gg
RecruitingNCT07559474Updated Jun 16, 2026

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 interventional study of INCB123667 in Hepatic Insufficiency and Liver Diseases, sponsored by Incyte Corporation. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic Insufficiency
  • Liver Diseases

Keywords

  • hepatic impairment
  • liver impairment (moderate and severe)
03

In context

Hepatic Insufficiency

113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.

This study's planned enrollment of 16 is below the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.

Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 by the medical monitor or investigator are eligible.
  • of 18.0 to 43.0 kg/m2 (inclusive).
  • Willingness to avoid pregnancy or fathering children.

Exclusion criteria

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 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 ≥ 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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Cohort 1: Moderate hepatic function

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

    Drug: INCB123667

  • Experimental
    Cohort 2: Severe hepatic function

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

    Drug: INCB123667

Interventions

06

What researchers measure

Primary outcomes

  1. PK for plasma INCB123667: Cmax

    Defined as the maximum plasma concentration.

    Time frame: Up to approximately 2 months

  2. PK for plasma INCB123667: AUCt

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

    Time frame: Up to approximately 2 months

  3. PK for plasma INCB123667: AUC∞

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

    Time frame: Up to approximately 2 months

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 2.5 months

07

Study locations

4 of 4 sites recruiting
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07559474
Lead sponsor
Incyte Corporation
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
May 27, 2026
Primary completion
Apr 13, 2027 (estimated)
Completion
Apr 13, 2027 (estimated)
Last update
Jun 16, 2026

Study contacts

Incyte Corporation Call Center (US)
Contact
medinfo@incyte.com
1.855.463.3463
Incyte Corporation Call Center (ex-US)
Contact
eumedinfo@incyte.com
+800 00027423
Incyte Medical Monitor
study director · Incyte Corporation

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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