Group 1: Severe Hepatic Impairment for Kidney Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Orange County Research Center, Tustin, CAKidney Disease+1 MoreINCB054707 - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Kidney Disease
  • Kidney Failure

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
S-217622
1
Group D-End-Stage Renal Disease (optional)
1
Group 1 -Mild Hepatic Impairment

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: Days 1 - 5

Days 1 - 5
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Pharmacokinetics Parameter: CL/F of INCB054707
Pharmacokinetics Parameter: Cmax of INCBC054707
Pharmacokinetics Parameter: t1/2 0f INCB054707
Pharmacokinetics Parameter: tmax of INCB054707
Pharmacokinetics Parameter:: Vz/F of INCB054707
up to 15 days
Number of Treatment Emergent Adverse Events (TEAE'S)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
S-217622
1
Group D-End-Stage Renal Disease (optional)
1
Group 1 -Mild Hepatic Impairment

Side Effects for

INCB054707
30%Upper respiratory tract infection
10%Nausea
10%Fibromyalgia
10%Headache
10%Anxiety
10%Night sweats
10%Rash
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03569371) in the INCB054707 ARM group. Side effects include: Upper respiratory tract infection with 30%, Nausea with 10%, Fibromyalgia with 10%, Headache with 10%, Anxiety with 10%.

Trial Design

4 Treatment Groups

Group 1: Severe Hepatic Impairment
1 of 4
Group 2: Moderate Hepatic Impairment
1 of 4
Group D: Normal Hepatic Function
1 of 4
Group 3: Mild Hepatic Impairment
1 of 4

Experimental Treatment

30 Total Participants · 4 Treatment Groups

Primary Treatment: Group 1: Severe Hepatic Impairment · No Placebo Group · Phase 1

Group 1: Severe Hepatic Impairment
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Group 2: Moderate Hepatic Impairment
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Group D: Normal Hepatic Function
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Group 3: Mild Hepatic Impairment
Drug
Experimental Group · 1 Intervention: INCB054707 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB054707
2018
Completed Phase 2
~80

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 1 - 5

Who is running the clinical trial?

Incyte CorporationLead Sponsor
323 Previous Clinical Trials
46,991 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top