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Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

NCT ID: NCT04534699

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2020-11-19

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate Hepatic Impairment Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hepatic Impaired

KBP-5074 0.5mg tablet orally, Single dose

Group Type EXPERIMENTAL

KBP-5074

Intervention Type DRUG

KBP-5074 tablet

Matched-control Healthy

KBP-5074 0.5mg tablet orally, Single dose

Group Type EXPERIMENTAL

KBP-5074

Intervention Type DRUG

KBP-5074 tablet

Interventions

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KBP-5074

KBP-5074 tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males or females, of any race, between 18 and 80 years of age, inclusive, at screening.
2. Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
3. Subjects with normal hepatic function must be in good health.
4. Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B.

Exclusion Criteria

1. Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
2. Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/2.
3. 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.
4. 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.
5. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Covance

INDUSTRY

Sponsor Role collaborator

KBP Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James McCabe

Role: STUDY_DIRECTOR

KBP Biosciences

Locations

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Orlando Clinical Research Center (OCRC)

Orlando, Florida, United States

Site Status

Texas Liver Institute (TLI)

San Antonio, Texas, United States

Site Status

Clinical Trials of Texas (CTT)

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38329646 (View on PubMed)

Other Identifiers

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KBP5074-1-006

Identifier Type: -

Identifier Source: org_study_id