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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RTA 402 5mg 3cap at fasting | Experimental |
| |
| RTA 402 5mg 3cap after meal | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bardoxolone methyl | Drug | Bardoxolone methyl 5 mg capsules |
|
| Measure | Description | 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 |
| Measure | Description | 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 | |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Corporation Heishinkai OPHAC Hospital | Osaka | 532-0003 | Japan |
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| ID | Term |
|---|---|
| C445068 | bardoxolone methyl |
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| Bardoxolone methyl | Drug | Bardoxolone methyl 5 mg capsules |
|
|
| 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 |