NCT01520727已完成1 期
A Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male Subjects
Bial - Portela C S.A.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年10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
- 64
- 试验地点
- 1
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
The purpose of this study was to investigate the safety, tolerability, pharmacokinetics and catechol-O-methyltransferase (COMT) activity of BIA 9-1067 in healthy male subjects after single oral ascending doses.
详细描述
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in up to 8 sequential groups of 8 healthy young male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 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.
- •Aged between 18 and 45 years, inclusive.
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
- •Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
排除标准
- •Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- •Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day
- •History of drug abuse within 1 year before study day
- •History of alcoholism within 1 year before day
- •Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- •Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- •Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
- •History of any clinically important drug allergy.
- •Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- •Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day
- •Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- •Donation of blood (i.e. 450 mL) within 60 days before study day 1
研究组 & 干预措施
BIA 9-1067 1200 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 1200 mg
干预措施: BIA 9-1067 (Drug)
Placebo
Placebo Comparator
Placebo (PLC): single-dose
干预措施: Placebo (Drug)
BIA 9-1067 10 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 10 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 25 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 25 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 50 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 50 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 100 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 100 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 200 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 200 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 400 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 400 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 800 mg
Experimental
BIA 9-1067 (Opicapone, OPC) - 800 mg
干预措施: BIA 9-1067 (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 7 weeks
Safety was evaluated from the number of reported adverse events (AEs)
次要结局
- Cmax - BIA 9-1067(pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose)
- Time to Cmax (Tmax)(pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP3700 in Healthy Male SubjectsHealthy VolunteersPharmacokinetics of ASP3700NCT02155504Astellas Pharma Europe B.V.44
终止
1 期
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP2205 in Healthy Young Males and Females and Elderly Females and to Evaluate the Effect of Food on the Pharmacokinetics of a Single Dose of of ASP2205Healthy SubjectsPharmacokinetics of ASP2205NCT02314793Astellas Pharma Europe B.V.93
已完成
1 期
A Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of E6007 in Healthy SubjectsInflammatory Bowel DiseaseNCT01221818Eisai Inc.48
已完成
1 期
A Single Ascending Dose Study of BMS-791325 in HCV Infected SubjectsChronic Hepatitis CNCT00664625Bristol-Myers Squibb24
已完成
1 期
A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected SubjectsChronic Hepatitis CNCT00546715Bristol-Myers Squibb95