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 — DRUGGroup 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 ImpairmentParticipants with severe renal impairment will be enrolled in Group 1.
- Experimental: Group 2: End Stage Renal DiseaseParticipants 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
- Incyte Corporation Call Center (US)1.855.463.3463
- Incyte Corporation Call Center (ex-US)+800 00027423
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