A Human AME Study for Omaveloxolone

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.

Criteria

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.