A Human AME Study for Omaveloxolone
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|ClinicalTrials.gov Identifier: NCT03931590|
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : January 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Male Subjects||Drug: [14C]-Omaveloxolone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects|
|Actual Study Start Date :||April 11, 2019|
|Actual Primary Completion Date :||May 31, 2019|
|Actual Study Completion Date :||May 31, 2019|
Experimental: Healthy Male Subjects
Single oral dose of 150 mg of [14C] omaveloxolone containing approximately 90 μCi as a capsule after an overnight fast of at least 10 hours.
[14C]-Omaveloxolone 50 mg capsules
Other Name: [14C]-RTA 408
- Maximum concentration (Cmax) of omaveloxolone [ Time Frame: 22 days ]Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
- Area under the omaveloxolone concentration-time curve (AUC) [ Time Frame: 22 days ]Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
- Maximum concentration of total radioactivity in blood and plasma [ Time Frame: 22 days ]Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity
- Area under the concentration-time curve total radioactivity in blood and plasma [ Time Frame: 22 days ]Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.
- Amount of radioactivity excreted in urine (Aeu) [ Time Frame: 22 days ]Rates and routes of elimination will be assessed by urine sampling for radioactivity.
- Amount of radioactivity excreted in feces (Aef) [ Time Frame: 22 days ]Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931590
|United States, Wisconsin|
|Covance Clinical Research Unit (CRU) Inc.|
|Madison, Wisconsin, United States, 53704|
|Principal Investigator:||Nicholas Siebers, MD||Covance CRU Inc.|