Renal ImpairmentPhase 1NCT05099445

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

A Phase 1 study testing INCB000928 in people with Renal Impairment and Hemodialysis, run by Incyte Corporation at 5 sites in United States.

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 multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level 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 Impairment, Hemodialysis
What is being tested?: INCB000928
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 5 sitesUnited States
Study dates: 14 Dec 2021to 27 Feb 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 82 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18 to 82 years (inclusive) at the time of signing the ICF.
Participants will be classified 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). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
Body mass index within the range 18.0 to 40.0 kg/m2 (inclusive) at screening.
Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
Ability to swallow and retain oral medication.

Who cannot join

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
Evidence of rapidly deteriorating renal function.
Participants who have a current, functioning organ transplant or have a scheduled 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.
Participants eligible for Group 1 who have a history of renal disease or renal injury as indicated by an abnormal, clinically significant renal function profile at screening or Day -1.

Show all 42Show fewer

Participants eligible for Groups 2 through 5 who 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.
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.
Participants eligible for Group 1 who have a history of using tobacco- or nicotine containing products within 6 months of screening.
Participants eligible for Groups 2 through 5 who 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) 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 30 days or 5 half-lives (whichever is longer) of study drug administration with strong or moderate inducer or inhibitor of CYP3A4 or P-gp (refer to the Drug Interaction Database Program [University of Washington School of Pharmacy 2002] for prohibited drugs).
Participants eligible for Group 1 who have used prescription drugs within 14 days of study drug administration or nonprescription medications/products (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of study drug administration. However, occasional acetaminophen and ibuprofen are permitted.
Participants eligible for Groups 2 through 5 who 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, or currently receiving systemic antibiotics. 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.
Participants eligible for Group 5 who are not expected to continue HD treatment for the duration of the study.
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 INCB000928 or excipients of INCB000928(refer to IB).
Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits;pose a significant risk to the participant; or interfere with interpretation of study data.
Women who are pregnant or breastfeeding.
QTc > 450 milliseconds for Groups 1 through 3 and QTc > 470 milliseconds for Group 4.
Participants eligible for Group 1 who 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.
Participants eligible for Groups 2 through 4 who 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).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Clinical Pharmacology of Miami
Hialeah, Florida, 33014
Advanced Pharma
Miami, Florida, 33147
Orlando Clinical Research Center
Orlando, Florida, 32809
Inland Empire Liver Foundation
Rialto, California, 92377
Nucleus Network Minneapolis Clinic
Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.

Conditions: Renal Impairment, Hemodialysis
Being tested: INCB000928
Keywords: renal impairment, hemodialysis, Kidney failure, end-stage renal disease, Fibrodysplasia ossificans progressiva
Medical subject headings: Renal Insufficiency, Kidney Failure, Chronic, Myositis Ossificans

What participants receive

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

INCB000928Drug
INCB000928 200 mg will be administered on Day 1 of each treatment period.

Study groups in NCT05099445
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 INCB000928 200 mg on Day 1. Receives: Drug: INCB000928
Group 2: Mild Renal Impairment	Experimental	Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Receives: Drug: INCB000928
Group 3: Moderate Renal Impairment	Experimental	Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Receives: Drug: INCB000928
Group 4: Severe Renal Impairment	Experimental	Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1. Receives: Drug: INCB000928
Group 5: Kidney Failure	Experimental	Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928. Receives: Drug: INCB000928

What is being measured

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

PK for plasma of INCB000928: Cmax
Defined as maximum observed plasma or serum concentration, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928
Measured: Days 1 - 4
PK for plasma of INCB000928: AUC0-t
Defined as area under the steady-state plasma or serum concentration-time curve over 1 dose interval, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
Measured: Days 1 - 4
PK for plasma of INCB000928: AUC0-∞
Defined as area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
Measured: Days 1 - 4

Secondary outcomes (6)

Number of treatment-related adverse events
To determine the safety and tolerability of INCB000928 administered as monotherapy in participants with with impaired renal function and hemodialysis.
Measured: Days 1-4 and follow up; up to 14 days
PK for plasma of INCB000928: tmax
Defined as time to maximum concentration
Measured: Days 1 - 4
PK for plasma of INCB000928: t½
Defined as apparent terminal-phase disposition half-life
Measured: Days 1 - 4
PK for plasma of INCB000928: CL/F
Defined as apparent oral dose clearance
Measured: Days 1 - 4
PK for plasma of INCB000928: Vz/F
Defined as apparent oral dose volume of distribution
Measured: Days 1 - 4
PK for plasma of INCB000928: AUC3-7
Group 5 only: Defined as area under the plasma or serum concentration-time curve from 3 to 7 h during dialysis, 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.

14 Dec 202127 Feb 2023

First posted29 Oct 2021
Study start14 Dec 2021
Primary completion19 Feb 2023
Study completion27 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Renal ImpairmentStudies 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: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05099445
Sponsor's protocol ID: INCB 00928-108
Status last verified: May 2023
First submitted: 18 Oct 2021
Last updated: 15 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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?

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All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
ClinicalTrials.gov ID: NCT05099445
Acronym / sponsor ID: INCB 00928-108
Conditions: Renal Impairment, Hemodialysis
Keywords: renal impairment, hemodialysis, Kidney failure, end-stage renal disease, Fibrodysplasia ossificans progressiva
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Incyte CorporationIndustry (pharma, biotech, devices)
Study start: 14 Dec 2021 (actual)
Primary completion: 19 Feb 2023 (actual)
Study completion: 27 Feb 2023 (actual)
First posted: 29 Oct 2021 (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 to evaluate single oral doses of INCB000928 in participants with varying level 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: INCB000928Participants with normal levels of renal function will receive a single oral dose of INCB000928 200 mg on Day 1.
Group 2: Mild Renal Impairment	Experimental	Drug: INCB000928Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group 3: Moderate Renal Impairment	Experimental	Drug: INCB000928Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group 4: Severe Renal Impairment	Experimental	Drug: INCB000928Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
Group 5: Kidney Failure	Experimental	Drug: INCB000928Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928.

Who may qualify

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

Key inclusion criteria (8 listed)

Age 18 to 82 years (inclusive) at the time of signing the ICF.
Participants will be classified 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). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.

Key exclusion criteria (42 listed)

History of uncontrolled or unstable cardiovascular, respiratory, hepatic, GI, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening.
Evidence of rapidly deteriorating renal function.
Participants who have a current, functioning organ transplant or have a scheduled 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.

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
INCB000928INCB000928 200 mg will be administered on Day 1 of each treatment period.	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

PK for plasma of INCB000928: Cmax
Time frame: Days 1 - 4
Defined as maximum observed plasma or serum concentration, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928
PK for plasma of INCB000928: AUC0-t
Time frame: Days 1 - 4
Defined as area under the steady-state plasma or serum concentration-time curve over 1 dose interval, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
PK for plasma of INCB000928: AUC0-∞
Time frame: Days 1 - 4
Defined as area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.

6 secondary outcomes

Number of treatment-related adverse events
Time frame: Days 1-4 and follow up; up to 14 days
PK for plasma of INCB000928: tmax
Time frame: Days 1 - 4
PK for plasma of INCB000928: t½
Time frame: Days 1 - 4
PK for plasma of INCB000928: CL/F
Time frame: Days 1 - 4
PK for plasma of INCB000928: Vz/F
Time frame: Days 1 - 4
PK for plasma of INCB000928: AUC3-7
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 15 May 2023.
Individual participant dataSharing planned: Yes. Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

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RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Not yet recruiting
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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.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INCB000928 in people with Renal Impairment and Hemodialysis, run by Incyte Corporation at 5 sites in United States.

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 8 inclusion and 42 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 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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?

PK for plasma of INCB000928: Cmax (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 NCT05099445.

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 15 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.