Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Moderate Hepatic Impairment
• Intervention / Treatment: Drug: KBP-5074

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center (OCRC)
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute (TLI)
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas (CTT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepatic Impaired; KBP-5074 0.5mg tablet orally, Single dose	Drug: KBP-5074; KBP-5074 tablet
Experimental: Matched-control Healthy; KBP-5074 0.5mg tablet orally, Single dose	Drug: KBP-5074; KBP-5074 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Parameter: Maximum observed concentration (Cmax)	Maximum observed concentration (Cmax) - Plasma	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	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	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	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	Up to 12 days

Collaborators and Investigators

• Sponsor: KBP Biosciences
• Collaborators: Covance
• Investigators: Study Director: James McCabe, KBP Biosciences

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Actual): November 19, 2020
• Study Completion (Actual): November 19, 2020

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Healthy; Hepatic Impairment; Moderate Hepatic Impairment; KBP-5074
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; KBP-5074
• Other Study ID Numbers: KBP5074-1-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No