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Group 2: Mild Renal Impairment 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 21 days

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%

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

~530

Do I qualify?Apply below to find out

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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

364 Previous Clinical Trials

55,141 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for participation in this medical study exclude individuals over seventy-five years old?

"As per the study's prerequisites, individuals aged 18 to 82 are welcomed as participants."

Answered by AI

Has the FDA issued approval for Group 1: Normal Renal Function?

"With limited data supporting efficacy and safety, Group 1: Normal Renal Function receives a score of 1."

Answered by AI

Could I potentially join the research effort for this clinical trial?

"Eligibility for this trial requires nephrotic failure and an age between 18 and 82. Currently, the plan is to recruit 24 participants in total."

Answered by AI

How many participants have joined this research endeavor?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is still enrolling participants and was last amended on December 1st 2023. The research team needs 24 people from a single site location for the experiment."

Answered by AI

Are there any vacancies for the clinical trial that are still to be filled?

"Clinicaltrials.gov reports that the recruitment process for this medical trial commenced on January 10th, 2023 and is still ongoing as of December 1st, 2023."

Answered by AI

What are the fundamental aims of this trial?

"The primary objective of this research, which is to be monitored over the span of four days, centers on measuring the Area Under Curve (AUC) of INCB054707. Secondary goals include determining the time it takes for maximum plasma concentration to reach its peak (tmax), as well as calculating half-life and clearance during dialysis in Group 5 Period 1."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

2023. "Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05694195.

All > Dialysis