A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Aged 18 to 85 years, inclusive, at the time of signing the ICF.
• Severe renal impairment or ESRD based on CKD-EPI.
• Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
• Willingness to avoid pregnancy or fathering children.
Locations
United States
Florida
Floridian Clinical Research
RECRUITING
Miami Lakes
Orlando Clinical Research Center
RECRUITING
Orlando
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date: 2026-05-29
Estimated Completion Date: 2027-01-04
Participants
Target number of participants: 16
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation