Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

NCT04534699 | Completed Phase 1 FDA Drug

• 1 other identifier: KBP5074-1-006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Moderate Hepatic Impairment; Healthy

Keywords

Hepatic Impairment; Moderate Hepatic Impairment; Healthy; KBP-5074

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Hepatic Impaired

EXPERIMENTAL

KBP-5074 0.5mg tablet orally, Single dose

Drug: KBP-5074

Matched-control Healthy

EXPERIMENTAL

KBP-5074 0.5mg tablet orally, Single dose

Drug: KBP-5074

Interventions

KBP-5074 DRUG

KBP-5074 tablet

Hepatic Impaired; Matched-control Healthy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KBP Biosciences: lead
• Covance: collaborator

Study Sites (3)

Orlando Clinical Research Center (OCRC)

Orlando, Florida, 32809, United States

Location

Texas Liver Institute (TLI)

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas (CTT)

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 38329646 DERIVED

MeSH Terms

Interventions

KBP-5074

Study Officials

• James McCabe

  KBP Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 1, 2020
• Study Start: August 27, 2020
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)