A Phase 1, Open-Label, Food Effect, And Dose Proportionality Study With Omaveloxolone In Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)
研究概览
简要总结
This study will determine the effect of food on the pharmacokinetics of omaveloxolone (150 mg) in healthy adult subjects and will assess the safety, tolerability, and dose proportionality of 50 mg, 100 mg, and 150 mg omaveloxolone in healthy adult subjects.
The study will be conducted in two parts, conducted simultaneously. Part 1 will assess the food effect, while Part 2 will assess dose proportionality.
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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female and age is between 18 and 55 years, inclusive;
- •All female subjects must have negative results for pregnancy tests performed;
- •If male, subject must be surgically sterile or practicing at least 1 of the following methods of contraception, from initial study drug administration through 90 days after administration of the last dose of study drug;
- •If male, subject agrees to abstain from sperm donation through 90 days after administration of the last dose of study drug;
- •Body Mass Index (BMI) is ≥ 18 to ≤ 31 kg/m2, inclusive;
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG), as judged by the investigator.
排除标准
- •Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the investigator;
- •Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines;
- •Requirement for any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements on a regular basis;
- •Recent (6-month) history of drug or alcohol abuse;
- •Receipt of any investigational product within a time period equal to 10 half-lives of the product, if known, or a minimum of 30 days prior to study drug administration;
- •Positive screen results for drugs of abuse, alcohol, or cotinine at screening or Day -1;
- •Consumption of alcohol within 72 hours prior to study drug administration;
- •Consumption of grapefruit, grapefruit products, star fruit, star fruit products, or Seville oranges within the 72-hour period prior to study drug administration;
- •Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration;
- •Current enrollment in another clinical study.
研究组 & 干预措施
Food Effect (Fasted)
Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fasted state (Period 1) with a crossover and then in the fed state (Period 2).
Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2.
干预措施: omaveloxolone (Drug)
Effect (Fed)
Subjects will be randomly assigned to one of the two treatment sequences. Two single doses of omaveloxolone 150 mg (taken in multiple 50 mg capsules) will be administered to the subjects beginning in the fed state (Period 1) with a crossover and then in the fasted state (Period 2).
Subjects will be confined beginning on Study Day -1 through the last PK blood draw on Study Day 6 during Period 1, and from Study Day 14 through the last PK blood draw on Study Day 20 during Period 2.
干预措施: omaveloxolone (Drug)
Dose Proportionality
Subjects will be randomly assigned to one of two omaveloxolone dosages. A single dose of omaveloxolone (in either 50 mg or 100 mg) will be administered to the subjects in 50 mg capsules in a fasted state.
Subjects will be confined beginning on Study Day -1 through the last blood sample collection on Study Day 6.
干预措施: omaveloxolone (Drug)
结局指标
主要结局
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring area under curve (AUC)
时间窗: 20 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under curve (AUC).
Determine the effect of food on the pharmacokinetics of omaveloxolone in healthy adult subjects by measuring maximum observed concentration (Cmax)
时间窗: 20 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
次要结局
- Incidence of treatment-emergent adverse events(6 days)