A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

NCT ID: NCT04023903

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-04
• Study Completion Date: 2019-06-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RTA 402 5mg 3cap at fasting

Group Type: EXPERIMENTAL

Bardoxolone methyl

Intervention Type: DRUG

Bardoxolone methyl 5 mg capsules

RTA 402 5mg 3cap after meal

Group Type: EXPERIMENTAL

Bardoxolone methyl

Intervention Type: DRUG

Bardoxolone methyl 5 mg capsules

Interventions

Bardoxolone methyl

Bardoxolone methyl 5 mg capsules

Intervention Type: DRUG

Bardoxolone methyl

Bardoxolone methyl 5 mg capsules

Intervention Type: DRUG

Other Intervention Names

RTA 402; RTA 402

Eligibility 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

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. Individuals who are positive for active antibodies produced by hepatitis B vaccination and are not infected with hepatitis B virus at screening can be enrolled in the study;

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Corporation Heishinkai OPHAC Hospital

Osaka, , Japan

Countries

Japan

Other Identifiers

RTA 402-009

Identifier Type: -

Identifier Source: org_study_id