drugset / Trial / NCT03340753
Bioavailability of KBP-5074 Tablet vs Capsule Formulations
Non-randomizedCrossoverOpen-labelBasic science
Summary
This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies.
Timeline
- Start
- 2017-10-26
- Primary completion
- 2017-11-22
- Completion
- 2017-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ocedurenone | Small molecule | 0.5 mg | — |
| Comparator | Ocedurenone | Small molecule | 1 mg | — |
Indications
No indication recorded.