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)

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

Study Overview

• Status: Completed
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: Bardoxolone methyl

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 532-0003
    • Medical Corporation Heishinkai OPHAC Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RTA 402 5mg 3cap at fasting	Drug: Bardoxolone methyl; Bardoxolone methyl 5 mg capsules; Other Names: RTA 402
EXPERIMENTAL: RTA 402 5mg 3cap after meal	Drug: Bardoxolone methyl; Bardoxolone methyl 5 mg capsules; Other Names: RTA 402

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 4, 2019
• Primary Completion (ACTUAL): June 14, 2019
• Study Completion (ACTUAL): June 14, 2019

Study Registration Dates

• First Submitted: July 16, 2019
• First Submitted That Met QC Criteria: July 16, 2019
• First Posted (ACTUAL): July 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Food effect; Bardoxolone Methyl; Healthy subject
• Other Study ID Numbers: RTA 402-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No