A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
- Conditions
- Healthy subject
- Registration Number
- JPRN-jRCT2080224786
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 64
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
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.;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>Cmax, AUC0-t
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>tmax, AUC0-inf, t1/2, MRT, kel