A Human AME Study for Omaveloxolone

Study Overview
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Brief Summary
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This study will assess the pharmacokinetics (PK), mass balance, metabolite profiles, and rates and routes of elimination of [14C] omaveloxolone and derived metabolites following administration as a single 150 mg (containing approximately 90 µCi) dose to healthy male subjects.

Detailed Description
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This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.

Official Title
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Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: [14C]-Omaveloxolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated: Males, of any race, between 18 and 55 years of age, inclusive. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, and a total body weight > 50 kg. Be surgically sterile or willing to agree to use contraception In good health, as assessed by the investigator (or designee). Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Exclusion Criteria: Significant history or clinical manifestation of any major system disorder, as determined by the investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs. Presence of any other condition, including surgery, known to interfere with the absorption, distribution, metabolism, or excretion of medicines. Abnormal laboratory values considered clinically significant by the investigator. Clinically significant abnormal 12-lead ECGs. History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day-1). Alcohol consumption of > 21 units per week. Positive urine drug screen at Screening, or positive alcohol breath test result or positive urine drug screen at Check-in (Day -1). Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known) prior to dosing. Current enrollment in another clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Male Subjects<br>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. | Drug: [14C]-Omaveloxolone<br>* [14C]-Omaveloxolone 50 mg capsules<br>* Other names: [14C]-RTA 408;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) of omaveloxolone | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax). | 22 days | 
| Area under the omaveloxolone concentration-time curve (AUC) | Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC). | 22 days | 
| Maximum concentration of total radioactivity in blood and plasma | Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity | 22 days | 
| Area under the concentration-time curve total radioactivity in blood and plasma | Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve. | 22 days | 
| Amount of radioactivity excreted in urine (Aeu) | Rates and routes of elimination will be assessed by urine sampling for radioactivity. | 22 days | 
| Amount of radioactivity excreted in feces (Aef) | Rates and routes of elimination will be assessed by sampling of feces for radioactivity. | 22 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RTA 408, RTA 408 capsules, omaveloxolone, omaveloxolone capsules, AME, mass balance, metabolite identification