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

Sponsor
Incyte Corporation
Study ID
NCT07559474
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Hepatic Insufficiency
  • Liver Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • INCB123667 — DRUG
    single dose administered orally

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Apr 13, 2027
Completion
Apr 13, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Moderate hepatic function
    Participants with moderate hepatic impairment will be enrolled in Cohort 1.
  • Experimental: Cohort 2: Severe hepatic function
    Participants with severe hepatic impairment will be enrolled in Cohort 2.

Primary Outcome Measure

PK for plasma INCB123667: Cmax [ Time Frame: Up to approximately 2 months ]

Central Contacts

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