A Clinical Pharmacology Study of Bardoxolone Methyl in Healthy Adults

Healthy Subject Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023903
• Other study ID #: RTA 402-009
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2019
• Est. completion date: June 14, 2019

Study information

• Verified date: February 2020
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 14, 2019
• Est. primary completion date: June 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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;

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• Bardoxolone methyl
Bardoxolone methyl 5 mg capsules
• Bardoxolone methyl
Bardoxolone methyl 5 mg capsules

Locations

Country	Name	City	State
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Primary	AUC0-t		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary	tmax		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary	AUC0-8		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary	t1/2		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary	MRT		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours
Secondary	kel		Pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 30, 36, 48, 60, 72, 96 hours