NCT04023903

A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

A Clinical Pharmacology Study of RTA 402 (Investigation of the Effect of Food on the Pharmacokinetics of RTA 402 Capsules in Japanese Healthy Adults and Comparison of the Pharmacokinetics With Those in Caucasian Healthy Adults)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 39 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Subject

Interventions

Type	Name	Description
DRUG	Bardoxolone methyl	Bardoxolone methyl 5 mg capsules
DRUG	Bardoxolone methyl	Bardoxolone methyl 5 mg capsules

Timeline

• Start date: 2019-04-04
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2019-07-18
• Last updated: 2020-02-05

Locations

1 site across 1 country: Japan