Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
- Registration Number
- NCT05099445
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: Mild Renal Impairment INCB000928 Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Group 5: Kidney Failure INCB000928 Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928. Group 3: Moderate Renal Impairment INCB000928 Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Group 4: Severe Renal Impairment INCB000928 Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Group 1: Normal Renal Function INCB000928 Participants with normal levels of renal function will receive a single oral dose of INCB000928 200 mg on Day 1.
- Primary Outcome Measures
Name Time Method PK for plasma of INCB000928: AUC0-∞ Days 1 - 4 Defined as area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
PK for plasma of INCB000928: Cmax Days 1 - 4 Defined as maximum observed plasma or serum concentration, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928
PK for plasma of INCB000928: AUC0-t Days 1 - 4 Defined as area under the steady-state plasma or serum concentration-time curve over 1 dose interval, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
- Secondary Outcome Measures
Name Time Method PK for plasma of INCB000928: AUC3-7 Days 1 - 4 Group 5 only: Defined as area under the plasma or serum concentration-time curve from 3 to 7 h during dialysis, Period 1.
Number of treatment-related adverse events Days 1-4 and follow up; up to 14 days To determine the safety and tolerability of INCB000928 administered as monotherapy in participants with with impaired renal function and hemodialysis.
PK for plasma of INCB000928: tmax Days 1 - 4 Defined as time to maximum concentration
PK for plasma of INCB000928: t½ Days 1 - 4 Defined as apparent terminal-phase disposition half-life
PK for plasma of INCB000928: CL/F Days 1 - 4 Defined as apparent oral dose clearance
PK for plasma of INCB000928: Vz/F Days 1 - 4 Defined as apparent oral dose volume of distribution
Trial Locations
- Locations (5)
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Nucleus Network Minneapolis Clinic
🇺🇸Saint Paul, Minnesota, United States
Clinical Pharmacology of Miami
🇺🇸Hialeah, Florida, United States
Advanced Pharma
🇺🇸Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States