NCT02305030已完成1 期
Effect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy Volunteers
Bial - Portela C S.A.0 个研究点目标入组 20 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- R- and S-warfarin plasma concentration
研究概览
简要总结
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days.
详细描述
Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50 mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose of 25 mg warfarin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed and dated informed consent form before any study-specific screening procedure was performed,
- •Male or female subjects aged 18 to 45 years, inclusive,
- •Body mass index (BMI) between 18 and 30 kg/m2,
- •Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG),
- •Negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies and anti-human immunodeficiency virus (HIV) antibodies at screening,
- •Clinical laboratory test results clinically acceptable at screening and at admission to each inpatient period,
- •Negative screen for alcohol and drugs of abuse at screening and at admission to each inpatient period,
- •Non-smokers or ex-smokers for at least 3 months,
- •Able to participate, and willing to give written informed consent and comply with the study restrictions,
- •Able to swallow a high number of capsules within a short time frame,
- •Was not of childbearing potential by reason of surgery or, if of childbearing potential, used an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for the entire duration of the study,
- •Negative serum pregnancy test at screening and a negative urine pregnancy test at admission to each inpatient period.
排除标准
- •Any clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or had a clinically relevant surgical history,
- •Any personal or family history of haemostatic disorder,
- •Any personal or family history of bleeding complications after surgery or tooth extraction, nose or gingival bleeding, or haemorrhagic diathesis,
- •Any clinically relevant findings in the laboratory tests, particularly any abnormality in the coagulation tests or the liver function tests,
- •History of relevant atopy or drug hypersensitivity,
- •History of alcoholism and/or drug abuse,
- •Current consumption of more than 14 units of alcohol per week [1 unit of alcohol = 280 mL beer (3-4°) = 100 mL wine (10-12°) = 30 mL spirits (40°)],
- •Any significant infection or known inflammatory process on screening or admission to each treatment period; any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period,
- •Use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion, or intake of any of the prohibited medications (i.e., CYP2C9 inhibitor taken within 1 week prior to start of administration of study drug, and CYP2C9 inducer taken within 4 weeks prior to dosing),
- •Previous use of opicapone,
- •Use of any investigational drug or participation in any clinical trial within 3 months prior to screening; participation in more than 2 clinical trials within the 12 months prior to screening,
- •Blood donation or receipt of any blood transfusion or any blood products within the 3 months prior to screening,
- •Vegetarian, vegan or had medical dietary restrictions,
- •Not able to communicate reliably with the investigator,
- •Unlikely to co-operate with the requirements of the study,
- •Unwilling or unable to give written informed consent,
- •CYP2C9 poor metaboliser, as assessed by genotyping,
- •Pregnant or breast-feeding.
研究组 & 干预措施
BIA 9-1067 / Warfarin
Experimental
BIA 9-1067 capsules of 25 mg or 50 mg Warfarin capsules of 5 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 / Warfarin
Experimental
BIA 9-1067 capsules of 25 mg or 50 mg Warfarin capsules of 5 mg
干预措施: Warfarin (Drug)
结局指标
主要结局
R- and S-warfarin plasma concentration
时间窗: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120 and 144 h post-warfarin
次要结局
- Opicapone plasma concentration(D1 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, and 8 h post-opicapone dose)
- BIA 9-1103 (sulphate metabolite) plasma concentration(D1 pre-dose and from D5 to D7 pre-dose, and on D8 at the following time points: pre-dose, 0.5, 2, 4, 6, 8, 24, 48, 72 and 144 h post-opicapone dose.)
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