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
Incyte Corporation
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
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. 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. * Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values wi…
Interventions
- DrugINCB123667
Group 1: Single dose administered orally. Group 2: Two single doses administered orally.
Locations (2)
- Floridian Clinical ResearchMiami Lakes, Florida
- Orlando Clinical Research CenterOrlando, Florida