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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-4 and follow up; up to 14 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the drug INCB000928 in people with different levels of kidney function. The goal is to see how the drug behaves in their bodies and its effects.
Eligible Conditions
- Kidney Failure
- Hemodialysis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-4 and follow up; up to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-4 and follow up; up to 14 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PK for plasma of INCB000928: AUC0-t
PK for plasma of INCB000928: AUC0-∞
PK for plasma of INCB000928: Cmax
Secondary study objectives
Number of treatment-related adverse events
PK for plasma of INCB000928: AUC3-7
PK for plasma of INCB000928: CL/F
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Group 5: Kidney FailureExperimental Treatment1 Intervention
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 II: Group 4: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group III: Group 3: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group IV: Group 2: Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group V: Group 1: Normal Renal FunctionExperimental Treatment1 Intervention
Participants with normal levels of renal function will receive a single oral dose of INCB000928 200 mg on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB000928
2021
Completed Phase 2
~70
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,787 Total Patients Enrolled
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