Status:
COMPLETED
A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Healthy Subject
Eligibility:
MALE
20-39 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04023903
Start Date
April 4 2019
End Date
June 14 2019
Last Update
February 5 2020
Active Locations (1)
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1
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan, 532-0003