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Group D: Normal Hepatic Function for Kidney Failure

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 - 5
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called INCB054707. It aims to see how the drug works in people with different levels of kidney function, from healthy to impaired. The study will help understand the drug's effects and safety in these different groups.

Eligible Conditions
  • Kidney Failure
  • Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 - 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 - 5 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Pharmacokinetics Parameter: Cmax of INCBC054707
Secondary study objectives
Number of Treatment Emergent Adverse Events (TEAE'S)
Pharmacokinetics Parameter: CL/F of INCB054707
Pharmacokinetics Parameter: t1/2 0f INCB054707
+2 more

Side effects data

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group D: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1.
Group II: Group 3: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Group III: Group 2: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1.
Group IV: Group 1: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 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
391 Previous Clinical Trials
63,899 Total Patients Enrolled

Media Library

INCB054707 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05624710 — Phase 1
Kidney Failure Research Study Groups: Group D: Normal Hepatic Function, Group 1: Severe Hepatic Impairment, Group 2: Moderate Hepatic Impairment, Group 3: Mild Hepatic Impairment
Kidney Failure Clinical Trial 2023: INCB054707 Highlights & Side Effects. Trial Name: NCT05624710 — Phase 1
INCB054707 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624710 — Phase 1
~9 spots leftby Oct 2025
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