Moderate Hepatic ImpairmentPhase 1NCT04534699
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
A Phase 1 study testing KBP-5074 in people with Moderate Hepatic Impairment and Healthy, run by KBP Biosciences at 3 sites in United States.
Trial summary
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Hepatic Impairment, Healthy
- What is being tested?
- KBP-5074
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Aug 2020to 19 Nov 2020
- 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
- Males or females, of any race, between 18 and 80 years of age, inclusive, at screening.
- Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
- Subjects with normal hepatic function must be in good health.
- Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B.
Who cannot join
- Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
- Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
- Use of mineralocorticoids or MRAs (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor.
- Subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Orlando Clinical Research Center (OCRC)
Orlando, Florida, 32809
Texas Liver Institute (TLI)
San Antonio, Texas, 78215
Clinical Trials of Texas (CTT)
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Open Label, Nonrandomized, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 in Subjects With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
- Conditions
- Moderate Hepatic Impairment, Healthy
- Being tested
- KBP-5074
- Keywords
- Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KBP-5074Drug
KBP-5074 tablet
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Impaired | Experimental | KBP-5074 0.5mg tablet orally, Single dose Receives: Drug: KBP-5074 |
| Matched-control Healthy | Experimental | KBP-5074 0.5mg tablet orally, Single dose Receives: Drug: KBP-5074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
Maximum observed concentration (Cmax) - Plasma
Measured: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Measured: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Measured: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax)
Time of the maximum observed concentration (tmax) - Plasma
Measured: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations
Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations
Measured: Up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start27 Aug 2020
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate Hepatic ImpairmentStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBP Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- James McCabe, Study director, KBP Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534699
- Sponsor's protocol ID
- KBP5074-1-006
- Status last verified
- Dec 2025
- First submitted
- 27 Aug 2020
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCabe J, Zhang J, Yang F, Benn V. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Ocedurenone (KBP-5074) in Individuals with Moderate Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2024 Mar;49(2):229-237. doi: 10.1007/s13318-024-00879-3. Epub 2024 Feb 8.
PubMed 38329646
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Nonrandomized, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 in Subjects With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT04534699
- Acronym / sponsor ID
- KBP5074-1-006
- Conditions
- Moderate Hepatic Impairment, Healthy
- Keywords
- Hepatic Impairment, Moderate Hepatic Impairment, Healthy, KBP-5074
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- KBP BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 1 Sep 2020 (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 multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatic Impaired | Experimental | Drug: KBP-5074KBP-5074 0.5mg tablet orally, Single dose |
| Matched-control Healthy | Experimental | Drug: KBP-5074KBP-5074 0.5mg tablet orally, Single dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females, of any race, between 18 and 80 years of age, inclusive, at screening.
- Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
- Subjects with normal hepatic function must be in good health.
- Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B.
Key exclusion criteria (5 listed)
- Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
- Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
- Use of mineralocorticoids or MRAs (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor.
- Subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.
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 |
|---|---|---|
| KBP-5074KBP-5074 tablet | Drug | Hepatic Impaired, Matched-control Healthy |
Primary outcome
Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
Time frame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Maximum observed concentration (Cmax) - Plasma
Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
Time frame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax)
Time frame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Time of the maximum observed concentration (tmax) - Plasma
Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations
Time frame: Up to 12 days
Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations
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 16 Dec 2025.
- Derived from this study: PubMed 38329646McCabe J, Zhang J, Yang F, Benn V. Pharmacokinetics of the Novel Nonsteroidal Mineralocorticoid Receptor Antagonist Ocedurenone (KBP-5074) in Individuals with Moderate Hepatic Impairment. Eur J Drug Metab Pharmacokinet. 2024 Mar;49(2):229-237. doi: 10.1007/s13318-024-00879-3. Epub 2024 Feb 8.
- 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.
James McCabe study director
KBP Biosciences
3 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 KBP-5074 in people with Moderate Hepatic Impairment and Healthy, run by KBP Biosciences at 3 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 4 inclusion and 5 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Pharmacokinetic Parameter: Maximum observed concentration (Cmax) (time frame: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.). The study lists 5 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 NCT04534699, which also lists 1 linked publication.
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 16 Dec 2025.