drugset / Trial / NCT03340753

Bioavailability of KBP-5074 Tablet vs Capsule Formulations

NCT03340753 ↗

Phase 1 Completed 20 enrolled KBP Biosciences Medpace, Inc. · collab
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

EvaluationDrugModalityDoseRoute
Comparator Ocedurenone Small molecule 0.5 mg —
Comparator Ocedurenone Small molecule 1 mg —

Indications

No indication recorded.