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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

Study Summary

This trial studies how a drug affects people with different kidney function levels.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Pharmacokinetics Parameter: Cmax of INCBC054707
Secondary outcome measures
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%
Rash
10%
Night sweats
10%
Nausea
10%
Fibromyalgia
10%
Headache
10%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
INCB054707

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
~530

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
364 Previous Clinical Trials
55,140 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

Frequently Asked Questions

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

Is enrollment for this experiment open to participants yet?

"Affirmative. Clinicaltrials.gov has documentation that this clinical trial, first announced on February 26th of 2023, is seeking applicants at the moment. 30 subjects are needed from 3 separate locations to complete the study's requirements."

Answered by AI

What goals is this study attempting to achieve?

"This trial, which is set to be evaluated over a five-day period, seeks to evaluate the Area Under Curve of INCB054707. Secondary endpoints include number of Treatment Emergent Adverse Events (TEAEs), apparent oral dose volume of distribution and oral dose clearance associated with INCB054707."

Answered by AI

Has the FDA sanctioned Group 1: Severe Hepatic Impairment as a safe treatment?

"The safety of Group 1: Severe Hepatic Impairment was rated as a 1, given that the clinical trial is in Phase 1 and only has limited evidence supporting its efficacy and security."

Answered by AI

Does the criteria for this research include those beyond 55 years of age?

"The age range for inclusion into this research is between 18 and 80. There are 46 trials designed specifically to cater to those under the age of majority, whereas 563 clinical studies accommodate seniors above 65 years old."

Answered by AI

How many individuals are currently participating in this research study?

"Affirmative. According to clinicaltrials.gov, this investigation is recruiting patients currently and was posted on the 26th of February 2023 with its last update occuring on the 15th November 2022. A total of 30 subjects must be found from 3 different locations for inclusion in the trial."

Answered by AI

Would I be eligible to participate in this research endeavor?

"This clinical trial has a participant requisition of 30 people, whose eligibility is determined by their age (18-80) and kidney failure status."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
2022. "A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624710.
~11 spots leftby Apr 2025
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