A Phase 1, Open-Label, 4-Part, Drug-Drug Interaction Study With Omaveloxolone in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
研究概览
简要总结
This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
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
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects must satisfy all of the following criteria at the Screening Visit unless otherwise stated:
- •Males or females, of any race, between 18 and 55 years of age, inclusive.
- •Body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight >50 kg.
- •In good health.
- •Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- •Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
排除标准
- •Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit, unless otherwise stated:
- •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 (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- •History of alcoholism or drug/chemical abuse within 2 years prior to Check in (Day 1).
- •Abnormal laboratory values considered clinically significant by the investigator
- •Clinically significant abnormal 12 lead ECGs
- •Personal history of unexplained syncopal events, or family history of long QT syndrome or sudden unexplained death in a young person.
- •Pulse rate <50 bpm or systolic blood pressure <110 mmHg.
- •Alcohol consumption of >21 units per week for males and >14 units for females.
- •Positive urine drug screen or positive alcohol breath test result or positive urine drug screen.
- •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 prior to dosing or 5 half lives (if known), whichever is longer, prior to dosing.
- •Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the investigator (or designee).
- •Have previously completed or withdrawn from this study or any other study investigating omaveloxolone, and have previously received the investigational product.
- •Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
研究组 & 干预措施
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: Omaveloxolone (Drug)
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: Midazolam oral solution (Drug)
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: Repaglinide 1 MG (Drug)
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: MetFORMIN 500 Mg Oral Tablet (Drug)
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: Rosuvastatin (Drug)
Omaveloxolone and Multiple Drugs (Part 1)
Single oral doses of 2 mg midazolam, 1 mg repaglinide, 500 mg metformin, and a 10 mg rosuvastatin/0.25 mg digoxin cocktail on Days 1, 2, 3, and 5, respectively, and 18, 19, 20, and 22, respectively. Oral doses of 150 mg omaveloxolone on Days 12 to 27
干预措施: Digoxin tablet (Drug)
Omaveloxolone & Gemfibrozil (Part 2)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18
干预措施: Omaveloxolone (Drug)
Omaveloxolone & Gemfibrozil (Part 2)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 600 mg gemfibrozil (twice daily) on Days 10 to 18
干预措施: Gemfibrozil Tablets (Drug)
Omaveloxolone and Itraconazole (Part 3)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18.
干预措施: Omaveloxolone (Drug)
Omaveloxolone and Itraconazole (Part 3)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 200 mg itraconazole on Days 10 to 18.
干预措施: Itraconazole capsule (Drug)
Omaveloxolone and Verapamil (Part 4)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18.
干预措施: Omaveloxolone (Drug)
Omaveloxolone and Verapamil (Part 4)
Single oral doses of 150 mg omaveloxolone on Days 1 and 13. Oral doses of 120 mg verapamil on Days 10 to 18.
干预措施: Verapamil Pill (Drug)
结局指标
主要结局
Part 1 - Maximum concentration (Cmax) of probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
时间窗: 28 days
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine maximum observed concentration (Cmax).
Part 1 - Area under the plasma concentration-time curve of (AUC) for probe drugs co-administered with omaveloxolone (midazolam, repaglinide, metformin, rosuvastatin, and digoxin)
时间窗: 28 days
Pharmacokinetics will be assessed by blood sampling for midazolam, repaglinide, metformin, rosuvastatin, and digoxin to determine area under the curve (AUC).
Part 2 - Maximum concentration (Cmax) of omaveloxolone
时间窗: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Part 4 - Area under the omaveloxolone concentration-time curve (AUC)
时间窗: 28 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Part 2 - Area under the omaveloxolone concentration-time curve (AUC)
时间窗: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Part 3 - Maximum concentration (Cmax) of omaveloxolone
时间窗: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
Part 3 - Area under the omaveloxolone concentration-time curve (AUC)
时间窗: 28 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine area under the curve (AUC).
Part 4 - Maximum concentration (Cmax) of omaveloxolone
时间窗: 23 days
Pharmacokinetics will be assessed by blood sampling for omaveloxolone to determine maximum observed concentration (Cmax).
次要结局
未报告次要终点