drugset / Trial / NCT04023903

A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

NCT04023903 ↗

Phase 1 Completed 36 enrolled Kyowa Kirin, Inc.
RandomizedCrossoverOpen-labelOther

Summary

Food effect part: To investigate the effect of food on the pharmacokinetics of RTA 402 and evaluate the safety of RTA 402 in Japanese healthy male adults, using the capsule formulations. Caucasian subject part: To investigate the pharmacokinetics of a single dose of RTA 402 administered in the fasted state and compare the pharmacokinetics with those observed in Japanese healthy male adults in the food effect part

Timeline

Start
2019-04-04
Primary completion
2019-06-14
Completion
2019-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 5 mg —

Indications

No indication recorded.