Renal InsufficiencyPhase 1NCT05624723

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

A Phase 1 study testing INCB054707 in people with Renal Insufficiency and Kidney Diseases, run by Incyte Corporation at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment. Read more about this study

Who is it for?: Ages 18 to 82 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency, Kidney Diseases
What is being tested?: INCB054707
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 2 sitesin 2 countries
Study dates: 12 Jan 2023to 7 Feb 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 82 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Classification at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations at screening and Day -1 (Groups 2 through 4) or Period 1 Day -1 (Group 5).
Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening.
Willingness to avoid pregnancy or fathering children

Who cannot join

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating renal function.
Current, functioning organ transplant or a cheduled organ transplant within 6 weeks after check-in.
History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
Eligible for Group 1 and have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.
Eligible for Groups 2 through 5 and have had a change in disease status within 30 days of screening, as documented by the participant's medical history and deemed clinically significant by the investigator.

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History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
Recent myocardial infarction (within 6 months of check-in)
New York Heart Association Class III or IV congestive heart failure
Unstable angina (within 6 months of check-in)
Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker)
Uncontrolled hypertension
Any major surgery within 4 weeks of screening.
Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
Blood transfusion within 4 weeks of Day -1 (for Groups 1 through 4) or Period 1 Day -1 (Group 5).
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
Positive test and symptomatic for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
Eligible for Group 1 and have a history of using tobacco- or nicotine-containing products within 6 months of screening.
Eligible for Groups 2 through 5 and smoke > 10 cigarettes per day or equivalent use of other tobacco- or nicotine-containing products and are unwilling to refrain from tobacco or nicotine use on dosing days and abide by CRU restrictions.
History of alcohol dependency within 3 months of screening.
Positive breath test for ethanol or positive urine or saliva screen for drugs of abuse (confirmed by repeat test) at screening or check-in that are not otherwise explained by permitted concomitant medications.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with another investigational medication or current enrollment in another investigational drug study.
Current treatment or treatment within 15 days or 5 half-lives (whichever is longer) before the first dose of study drug with moderate and potent inducers or inhibitors of CYP3A4 (refer to the Drug Interaction Database Program [University of Washington School of Pharmacy 2002] for prohibited drugs).
Consumption of Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or fruit juices within 72 hours before the first dose of study drug.
Eligible for Group 1 and have used prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and hytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional use of acetaminophen and ibuprofen is permitted (see Section 6.6.1).
Eligible for Groups 2 through 5 and have used prescription drugs within 14 days of study drug administration, with the exception of established therapy for renal disease and the treatment of associated disorders that have been stable for at least 7 days prior to study drug administration, as approved by the investigator and in consultation with the sponsor's medical monitor.
Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, currently receiving systemic antibiotics, or having a current clinically significant viral infection at screening or check-in.
History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
Inability to undergo venipuncture or tolerate venous access.
Eligible for Group 5 and not expected to continue HD treatment for the duration of the study.
Women who are pregnant or breastfeeding.
Use of hormonal contraception
QTcF > 450 milliseconds for Groups 1 through 3 and QTcF > 470 milliseconds for Group 4.
Eligible for Group 1 and have abnormal LFT values, defined as aspartate aminotransferase, alanine aminotransferase, and serum (total and direct) bilirubin, as well as amylase and lipase above the upper limit of the normal range at screening.
Eligible for Groups 2 through 4 and have values outside the normal ranges for LFTs; however, values may be acceptable if they are consistent with the participant's renal condition (if stable for 1 month prior to screening) and if the investigator (or designee) and the sponsor feel that the results are not clinically significant (based on age and renal impairment status).
Receipt of live (including attenuated) vaccines within 3 months of check-in or anticipation of need for such a vaccine during the study (Note: Nonlive or inactivated vaccines are allowed up to 2 weeks prior to the first dose of study drug).
Known hypersensitivity or severe reaction to INCB054707 or excipients of INCB054707 (refer to the IB).

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

Germany1 site

Apex Gmbh
Munich, D-81241

Other trials in Germany

About this study

Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment.

Conditions: Renal Insufficiency, Kidney Diseases
Being tested: INCB054707
Keywords: renal impairment, hemodialysis, Kidney failure, end-stage renal disease
Medical subject headings: Renal Insufficiency, Kidney Diseases, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INCB054707Drug
Also called Povorcitinib
INCB054707 75 mg will be administered orally

Study groups in NCT05624723
Study group	Role	What they receive
Group 1: Normal Renal Function	Experimental	Participants with normal levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. Receives: Drug: INCB054707
Group 2: Mild Renal Impairment	Experimental	Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. Receives: Drug: INCB054707
Group 3: Moderate Renal Impairment	Experimental	Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. Receives: Drug: INCB054707
Group 4: Severe Renal Impairment	Experimental	Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1. Receives: Drug: INCB054707
Group 5: Kidney Failure	Experimental	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. Receives: Drug: INCB054707

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics Parameter: Cmax of INCB054707
Defined as maximum observed plasma concentration of INCB054707
Measured: Days 1-4
Pharmacokinetics Parameter: AUC0-t of INCB054707
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Measured: Days 1-4
Pharmacokinetics Parameter: AUC0-∞ of INCB54707
Defined as under the concentration-time curve up to the last measurable concentration of INCB054707
Measured: Days 1-4

Secondary outcomes (6)

Number of Treatment Emergent Adverse Events (TEAE'S)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measured: Up to 21 days
Pharmacokinetics Parameter: tmax of INCB054707
Defined as time to reach maximum plasma concentration of INCB054707; during dialysis for Group 5 Period 1.
Measured: Days 1-4
Pharmacokinetics Parameter: t½ of INCB054707
Defined as apparent terminal-phase disposition half-life of INCB054707; during dialysis for Group 5 Period 1.
Measured: Days 1-4
Pharmacokinetics Parameter: CL/F of INCB054707
Defined as oral dose clearance of INCB054707; during dialysis for Group 5 Period 1.
Measured: Days 1-4
Pharmacokinetics Parameter: Vz/F of INCB054707
Defined as apparent oral dose volume of distribution; during dialysis for Group 5 Period 1.
Measured: Days 1-4
Pharmacokinetics Parameter: AUC3-7 of INCB054707
Defined as area under the concentration-time curve from 1 to 5 of INCB054707; during dialysis for Group 5 Period 1.
Measured: Days 1-4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 20237 Feb 2024

First posted22 Nov 2022
Study start12 Jan 2023
Primary completion7 Feb 2024
Study completion7 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
More trials run by Incyte CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05624723
Sponsor's protocol ID: INCB054707-106
Status last verified: Feb 2024
First submitted: 11 Nov 2022
Last updated: 13 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Renal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis
ClinicalTrials.gov ID: NCT05624723
Acronym / sponsor ID: INCB054707-106
Conditions: Renal Insufficiency, Kidney Diseases
Keywords: renal impairment, hemodialysis, Kidney failure, end-stage renal disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 12 Jan 2023 (actual)
Primary completion: 7 Feb 2024 (actual)
Study completion: 7 Feb 2024 (actual)
First posted: 22 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-center, open-label, parallel-group study to evaluate oral doses of INCB054707 in participants with varying levels of renal function or impairment.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1: Normal Renal Function	Experimental	Drug: INCB054707Participants with normal levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 2: Mild Renal Impairment	Experimental	Drug: INCB054707Participants with mild levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 3: Moderate Renal Impairment	Experimental	Drug: INCB054707Participants with moderate levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 4: Severe Renal Impairment	Experimental	Drug: INCB054707Participants with severe levels of renal function will receive a single oral dose of INCB054707 75 mg on Day 1.
Group 5: Kidney Failure	Experimental	Drug: INCB054707Group 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.

Who may qualify

Ages: 18 to 82 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Classification at screening by renal function based on eGFR as calculated by the MDRD formula and requirement for HD (Group 5).
Participants eligible for Group 5 with ESRD have received HD for at least 3 months prior to screening.
Participants eligible for Group 1 should be in good health as determined by no clinically significant deviations from normal for medical history, physical examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at screening or Day -1.
Participants eligible for Groups 2 through 5 may have medical findings consistent with their degree of renal dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations at screening and Day -1 (Groups 2 through 4) or Period 1 Day -1 (Group 5).
Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening.

Key exclusion criteria (37 listed)

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating renal function.
Current, functioning organ transplant or a cheduled organ transplant within 6 weeks after check-in.
History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
History of clinically significant GI disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
Eligible for Group 1 and have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INCB054707Also: PovorcitinibINCB054707 75 mg will be administered orally	Drug	Group 1: Normal Renal Function, Group 2: Mild Renal Impairment, Group 3: Moderate Renal Impairment, Group 4: Severe Renal Impairment, Group 5: Kidney Failure

Primary outcome

Pharmacokinetics Parameter: Cmax of INCB054707
Time frame: Days 1-4
Defined as maximum observed plasma concentration of INCB054707
Pharmacokinetics Parameter: AUC0-t of INCB054707
Time frame: Days 1-4
Area Under the concentration- time curve up to the last measurable concentration of INCB054707
Pharmacokinetics Parameter: AUC0-∞ of INCB54707
Time frame: Days 1-4
Defined as under the concentration-time curve up to the last measurable concentration of INCB054707

6 secondary outcomes

Number of Treatment Emergent Adverse Events (TEAE'S)
Time frame: Up to 21 days
Pharmacokinetics Parameter: tmax of INCB054707
Time frame: Days 1-4
Pharmacokinetics Parameter: t½ of INCB054707
Time frame: Days 1-4
Pharmacokinetics Parameter: CL/F of INCB054707
Time frame: Days 1-4
Pharmacokinetics Parameter: Vz/F of INCB054707
Time frame: Days 1-4
Pharmacokinetics Parameter: AUC3-7 of INCB054707
Time frame: Days 1-4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
Individual participant dataSharing planned: No

Related trials for Renal Insufficiency

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB054707 in people with Renal Insufficiency and Kidney Diseases, run by Incyte Corporation at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Parameter: Cmax of INCB054707 (time frame: Days 1-4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05624723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.