Renal InsufficiencyPhase 1NCT05624710
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
A Phase 1 study testing INCB054707 in people with Renal Insufficiency and Kidney Diseases, run by Incyte Corporation at 4 sites in 2 countries.
Trial summary
This is a multicenter, open-label, parallel-group study to evaluate INCB054707 in participants with varying levels of renal function or impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Dec 2022to 30 Jun 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different.
- If the hepatic function classification for the participant is not similar at the 2 timepoints, enrollment of the participant into a hepatic category group will be at the discretion of the investigator, in consultation with the sponsor's medical monitor. The enrollment group will be based on the results at screening.
- Participants eligible for Group 4 (normal hepatic function) should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECGs, or laboratory examinations at screening or check-in.
- Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the investigator are eligible.
- BMI within the range of 18.0 to 44.0 kg/m2 (inclusive) at screening.
- Willingness to avoid pregnancy or fathering children.
Who cannot join
- the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating hepatic function.
- Serum corrected calcium and phosphorus levels over the upper limits of the institutional normal ranges.
- 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).
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- Clinically significant (symptomatic) cardiac arrhythmias (eg, sustained ventricular tachycardia, second or third degree atrioventricular block without a pacemaker).
- Uncontrolled hypertension.
- A current, functioning organ transplant or a scheduled organ transplant in the next 6 weeks from 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.
- Severe ascites (ascites requiring paracentesis more than every 4 weeks) or an encephalopathy ≥ Grade 2 (precludes them from understanding and signing an informed consent).
- 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 check-in.
- Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics or current clinically significant viral infection at screening or check-in.
- Positive serology for HBV (eg, HBsAg) or HIV. Participants whose results are compatible with immunity due to infection or prior immunization for HBV may be included at the discretion of the investigator.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
San Antonio, Texas, 78215
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
This is a multicenter, open-label, parallel-group study to evaluate 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 on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. Receives: Drug: INCB054707 |
| Group 2: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. Receives: Drug: INCB054707 |
| Group 3: Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. Receives: Drug: INCB054707 |
| Group D: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1. Receives: Drug: INCB054707 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics Parameter: Cmax of INCBC054707
Defined as maximum observed plasma concentration of INCB054707
Measured: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.
Measured: Days 1 - 5
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Defined as area under the concentration-time curve From 0 to Infinity of INCB054707
Measured: Days 1 - 5
Secondary outcomes (5)
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 15 days
Pharmacokinetics Parameter: tmax of INCB054707
Defined as time to reach maximum plasma concentration of INCB054707
Measured: Days 1 - 5
Pharmacokinetics Parameter: t1/2 0f INCB054707
Defined as apparent terminal phase disposition half-life of INCB54707
Measured: Days 1 - 5
Pharmacokinetics Parameter: CL/F of INCB054707
Defined as oral dose clearance of INCB054707
Measured: Days 1 - 5
Pharmacokinetics Parameter:: Vz/F of INCB054707
Defined as apparent oral dose volume of distribution of INCB054707
Measured: Days 1 - 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start8 Dec 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624710
- Sponsor's protocol ID
- INCB 54707-105
- Other IDs
- 2022-002660-70
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. 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 and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT05624710
- Acronym / sponsor ID
- INCB 54707-105
- 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
- 25 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (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 multicenter, open-label, parallel-group study to evaluate 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Severe Hepatic Impairment | Experimental | Drug: INCB054707Participants with severe hepatic impairment (Class C Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group 2: Moderate Hepatic Impairment | Experimental | Drug: INCB054707Participants with moderate hepatic impairment (Class B Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group 3: Mild Hepatic Impairment | Experimental | Drug: INCB054707Participants with mild hepatic impairment (Class A Child-Pugh score) will receive a single oral dose of INCB054707 on Day 1. |
| Group D: Normal Hepatic Function | Experimental | Drug: INCB054707Participants with normal hepatic function will receive a single oral dose of INCB054707 on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with hepatic impairment will be classified at screening based on Child-Pugh score. Classification will be repeated at check-in and should not be significantly different.
- If the hepatic function classification for the participant is not similar at the 2 timepoints, enrollment of the participant into a hepatic category group will be at the discretion of the investigator, in consultation with the sponsor's medical monitor. The enrollment group will be based on the results at screening.
- Participants eligible for Group 4 (normal hepatic function) should be in good health as determined by no clinically significant findings in the medical history, physical examination, vital signs, 12-lead ECGs, or laboratory examinations at screening or check-in.
- Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction, as determined by medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory examinations at screening and check-in. Participants with abnormal findings considered not clinically significant by the investigator are eligible.
- BMI within the range of 18.0 to 44.0 kg/m2 (inclusive) at screening.
Key exclusion criteria (17 listed)
- the opinion of the principal investigator, history of uncontrolled or unstable cardiovascular, respiratory, renal, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening or evidence of rapidly deteriorating hepatic function.
- Serum corrected calcium and phosphorus levels over the upper limits of the institutional normal ranges.
- 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:
- A current, functioning organ transplant or a scheduled organ transplant in the next 6 weeks from 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.
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 on Day 1. | Drug | Group 1: Severe Hepatic Impairment, Group 2: Moderate Hepatic Impairment, Group 3: Mild Hepatic Impairment, Group D: Normal Hepatic Function |
Primary outcome
Pharmacokinetics Parameter: Cmax of INCBC054707
Time frame: Days 1 - 5
Defined as maximum observed plasma concentration of INCB054707
Pharmacokinetics Parameter: AUC(0-t) of INCB054707
Time frame: Days 1 - 5
Defined as the area under the concentration- time curve up to the last measurable concentration of INCB54707.
Pharmacokinetics Parameter: AUC(0-∞) of INCB054707
Time frame: Days 1 - 5
Defined as area under the concentration-time curve From 0 to Infinity of INCB054707
5 secondary outcomes
Number of Treatment Emergent Adverse Events (TEAE'S)
Time frame: up to 15 days
Pharmacokinetics Parameter: tmax of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: t1/2 0f INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter: CL/F of INCB054707
Time frame: Days 1 - 5
Pharmacokinetics Parameter:: Vz/F of INCB054707
Time frame: Days 1 - 5
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
4 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 4 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 17 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 INCBC054707 (time frame: Days 1 - 5). 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?
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 3 Aug 2025.