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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224786

Enrollment

Registered

2019-07-16

Start date

2019-04-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subject

Interventions

investigational material(s) Generic name etc : RTA 402 INN of investigational material : Bardoxolone methyl Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administratio

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Written voluntary informed consent to participate in the study; 2) [Food Effect Part] Japanese men 20 to <40 years of age at informed consent; [Caucasian Subject Part] Caucasian men 20 to <40 years of age at informed consent; 3) BMI 18.5 kg/m2 to <25.0 kg/m2 at screening

Exclusion criteria

Exclusion criteria: 1) Presence of any disease requiring treatment; 2) History of heart failure (e.g., history of diagnosis of congestive heart failure categorized as Class III or IV of the New York Heart Association (NYHA) Functional Classification or history of hospitalization due to heart failure); 3) Alcoholism or drug addiction, or any positive result on drug abuse testing; 4) History of or current drug allergy; 5) Any positive result on infectious disease testing.;

Design outcomes

Primary

Measure	Time frame
pharmacokinetics Cmax, AUC0-t	—

Secondary

Measure	Time frame
pharmacokinetics tmax, AUC0-inf, t1/2, MRT, kel	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026