Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C] Omaveloxolone Following Single Oral Dose Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax) of omaveloxolone
研究概览
简要总结
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.
详细描述
Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy Male Subjects
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.
干预措施: [14C]-Omaveloxolone (Drug)
结局指标
主要结局
Maximum concentration (Cmax) of omaveloxolone
时间窗: 22 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Area under the omaveloxolone concentration-time curve (AUC)
时间窗: 22 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Area under the concentration-time curve total radioactivity in blood and plasma
时间窗: 22 days
Mass balance and metabolite profiles will be assessed by blood sampling for total radioactivity to determine area under the concentration-time curve.
Amount of radioactivity excreted in urine (Aeu)
时间窗: 22 days
Rates and routes of elimination will be assessed by urine sampling for radioactivity.
Amount of radioactivity excreted in feces (Aef)
时间窗: 22 days
Rates and routes of elimination will be assessed by sampling of feces for radioactivity.
Maximum concentration of total radioactivity in blood and plasma
时间窗: 22 days
Mass balance and metabolite profiles will be assessed by blood sampling for omaveloxolone to determine maximum concentration of total radioactivity
次要结局
未报告次要终点