A Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease

Sponsor
Incyte Corporation
Study ID
NCT07559396
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • INCB123667 — DRUG
    Group 1: Single dose administered orally. Group 2: Two single doses administered orally.

Study Details

This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.

Key Dates

Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Jan 4, 2027
Completion
Jan 4, 2027

Study Design

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

Arms

  • Experimental: Group 1: Severe Renal Impairment
    Participants with severe renal impairment will be enrolled in Group 1.
  • Experimental: Group 2: End Stage Renal Disease
    Participants with end stage renal disease will be enrolled in Group 2.

Primary Outcome Measure

PK for plasma INCB123667: Cmax [ Time Frame: Up to approximately 3 months ]

Central Contacts

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