A Human AME Study for Omaveloxolone

Launched by BIOGEN · Apr 25, 2019

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility 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.