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

408-C-1805

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.

2019-04-11

2019-05-31

2019-05-31

Completed

Early phase I

8

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 8, 'type': 'ACTUAL'}}

2024-02-02