drugset / Trial / NCT02653014

Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment

NCT02653014 ↗

Phase 1 Completed 26 enrolled KBP Biosciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III study.

Timeline

Start
2015-07-29
Primary completion
2016-05-26
Completion
2017-03-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Ocedurenone Small molecule 0.5 mg —
Subject Ocedurenone Small molecule 2.5 mg —
Subject Ocedurenone Small molecule 5 mg —