Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment

Phase 1 Completed 12 enrolled KBP Biosciences Covance · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2020-08-27
Primary completion: 2020-11-19
Completion: 2020-11-19

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ocedurenone	Small molecule	0.5 mg	Oral

Indications

No indication recorded.