drugset / Trial / NCT02653014
Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects and Subjects With Renal Impairment
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ocedurenone | Small molecule | 0.5 mg | — |
| Subject | Ocedurenone | Small molecule | 2.5 mg | — |
| Subject | Ocedurenone | Small molecule | 5 mg | — |