A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Patients With at Least One Adverse Event
研究概览
简要总结
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
详细描述
Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 is 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 electrocardiogram (ECG).
- •Nonsmoker 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
- •Have previously received BIA 9-
- •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 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 (ie 450 ml) within 90 days before study day 1.
研究组 & 干预措施
BIA 9-1067 5 mg
BIA 9-1067 (OPC, Opicapone) 5 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 10 mg
BIA 9-1067 (OPC, Opicapone) 10 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 20 mg
BIA 9-1067 (OPC, Opicapone) 20 mg
干预措施: BIA 9-1067 (Drug)
BIA 9-1067 30 mg
BIA 9-1067 (OPC, Opicapone) 30 mg
干预措施: BIA 9-1067 (Drug)
Placebo
Placebo, PLC
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients With at Least One Adverse Event
时间窗: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
次要结局
未报告次要终点