Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

Phase 1

Waitlist Available

Research Sponsored by Incyte Corporation

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-4 and follow up; up to 14 days for reporting.

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 more

Awards & 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