A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

NCT04023903 | Completed Phase 1

• 1 other identifier: RTA 402-009
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Bardoxolone Methyl; Healthy subject; Food effect

Outcome Measures

Primary Outcomes (2)

• Cmax

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

• AUC0-t

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

Secondary Outcomes (5)

• tmax

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

• AUC0-∞

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

• t1/2

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

• MRT

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

• kel

  Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours

Study Arms (2)

RTA 402 5mg 3cap at fasting

EXPERIMENTAL

Drug: Bardoxolone methyl

RTA 402 5mg 3cap after meal

EXPERIMENTAL

Drug: Bardoxolone methyl

Interventions

Bardoxolone methyl DRUG

Bardoxolone methyl 5 mg capsules

Also known as: RTA 402

RTA 402 5mg 3cap at fasting

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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

You may not qualify if:

• Presence of any disease requiring treatment;
• 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);
• Alcoholism or drug addiction, or any positive result on drug abuse testing;
• History of or current drug allergy;
• 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;

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (1)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, 532-0003, Japan

Location

MeSH Terms

Interventions

bardoxolone methyl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 18, 2019
• Study Start: April 4, 2019
• Primary Completion: June 14, 2019
• Study Completion: June 14, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

JP (1)