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Group 1: Normal Renal Function for Kidney Disease

Phase 1
Recruiting
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 up to 21 days
Awards & highlights

Study Summary

This trial tests a drug to treat kidney problems in people with different levels of kidney function.

Eligible Conditions
  • Kidney Disease
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics Parameter: AUC0-t of INCB054707
Pharmacokinetics Parameter: AUC0-∞ of INCB54707
Pharmacokinetics Parameter: Cmax of INCB054707
Secondary outcome measures
Number of Treatment Emergent Adverse Events (TEAE'S)
Pharmacokinetics Parameter: AUC3-7 of INCB054707
Pharmacokinetics Parameter: CL/F of INCB054707
+3 more

Side effects data

From 2019 Phase 2 trial • 10 Patients • NCT03569371
30%
Upper respiratory tract infection
10%
Rash
10%
Night sweats
10%
Nausea
10%
Fibromyalgia
10%
Headache
10%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707

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 INCB054707 across 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB054707.
Group II: Group 4: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group III: Group 3: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group IV: Group 2: Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 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 INCB054707 75 mg on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Incyte CorporationLead Sponsor
368 Previous Clinical Trials
55,437 Total Patients Enrolled
~10 spots leftby May 2025
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