A Human AME Study for Omaveloxolone

Reata Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Male Subjects

Treatments

Drug: [14C]-Omaveloxolone

Study type

Interventional

Funder types

Industry

Identifiers

NCT03931590

408-C-1805

Details and patient eligibility

About

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.

Full description

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Enrollment

8 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.