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CompletedNCT04023903Updated Feb 5, 2020

A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

A Phase 1 interventional study of Bardoxolone methyl and Bardoxolone methyl in Healthy Subject, sponsored by Kyowa Kirin Co., Ltd.. Completed at 1 site in Japan. Open to male participants aged 20 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Kyowa Kirin Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2019, registered Jul 2019).
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy Subject

Keywords

  • Bardoxolone Methyl
  • Healthy subject
  • Food effect
03

In context

Lead sponsor

Kyowa Kirin Co., Ltd. is the lead sponsor of 155 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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. 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;
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    RTA 402 5mg 3cap at fasting

    Drug: Bardoxolone methyl

  • Experimental
    RTA 402 5mg 3cap after meal

    Drug: Bardoxolone methyl

Interventions

  • DrugBardoxolone methyl

    Bardoxolone methyl 5 mg capsules

    Also known as: RTA 402

  • DrugBardoxolone methyl

    Bardoxolone methyl 5 mg capsules

    Also known as: RTA 402

06

What researchers measure

Primary outcomes

  1. Cmax

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

  2. AUC0-t

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

Secondary outcomes

  1. tmax

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

  2. AUC0-∞

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

  3. t1/2

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

  4. MRT

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

  5. kel

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

07

Study locations

1 site
  • Medical Corporation Heishinkai OPHAC Hospital
    Osaka, 532-0003, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04023903
Lead sponsor
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Jul 18, 2019
Start date
Apr 4, 2019
Primary completion
Jun 14, 2019
Completion
Jun 14, 2019
Last update
Feb 5, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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