Effect of Food on BIA 5-1058 Bioavailability in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The aim of this study is to investigate the effect of food on the pharmacokinetic (PK) profile of BIA 5-1058 after a single dose in healthy subjects.
详细描述
Single-centre, open-label, randomised, single-dose, three-way crossover, three-part study in 54 healthy subjects.
Duration of treatment:
The study comprised a screening evaluation between 2 and 28 days before the first IMP (Investigational Medicinal Product) administration and 3 treatment periods of approximately 4 days, separated by wash-out periods of at least 7 days. A follow-up visit was performed approximately 7 days after discharge from the last period or early discontinuation. For each subject, the full duration of the participation in the study was approximately 9 weeks.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able and willing to give written informed consent and to comply with the study restrictions;
- •Male or female subjects aged 18 to 45 years, inclusive;
- •Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
- •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 antibodies (HCV Ab) and anti-human immunodeficiency virus antibodies (HIV-1 and HIV-2 Ab) at screening;
- •Clinical laboratory test results clinically acceptable at screening and admission to each treatment period;
- •Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period;
- •Non-smokers or ex-smokers for at least 3 months.
- •No childbearing potential by reason of surgery or at least 1 year post menopause (i.e., 12 months post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing;
- •If of childbearing potential, she was using 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 is the sole partner of that subject] for all the duration of the study;
- •Negative serum pregnancy test at screening and negative urine pregnancy test on admission of each treatment period (women of childbearing potential only).
- •Using an effective method of contraception with a pregnant partner or partner of childbearing potential (condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomy) throughout the study;
- •Refraining from donating sperm throughout the study.
排除标准
- •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;
- •Clinically relevant surgical history;
- •History of relevant atopy or drug hypersensitivity;
- •History of alcoholism or drug abuse;
- •Consumption of more than 14 units of alcohol a week [1 glass (25 cL) of beer with 3° of alcohol = 7.5 g, or 1 glass (25 cL) of beer with 6° of alcohol = 15 g, or 1 glass (12.5 cL) of wine with 10° of alcohol = 12 g, or 1 glass (4cL) of aperitif with 42° of alcohol = 17 g];
- •Significant infection or known inflammatory process at screening or admission to each treatment period;
- •Display of 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 the first period that may could affect the safety or other study assessments, in the Investigator's opinion;
- •Previous administration of BIA 5-1058;
- •Use of any investigational drug or participation in any clinical trial within 90 days prior to screening;
- •Participation in more than 2 clinical trials within the 12 months prior to screening;
- •Donation or reception of any blood or blood products within the 3 months prior to screening;
- •Vegetarians, vegans or had any other medical dietary restrictions;
- •Not able to communicate reliably with the Investigator;
- •Unlikely to co-operate with the requirements of the study.
- •Pregnant or breastfeeding;
- •Not using an accepted effective contraceptive method or was using oral contraceptives.
- •Not using an accepted effective method of contraception;
- •Refusing to refrain from donating sperm throughout the study.
研究组 & 干预措施
PART 1 (400 mg BIA 5-1058)
Each subject was orally administered a single oral dose of BIA 5-1058 on D1 (dosing day) on three different occasions (Period 1, Period 2 and Period 3): Part 1: 400 mg BIA 5-1058 as four (4) 100 mg tablets in Period 1, 400 mg BIA 5-1058 as four (4) 100 mg tablets in Period 2, and 400 mg BIA 5-1058 as four (4) 100 mg tablets in Period 3.
干预措施: BIA 5-1058 (Drug)
PART 2 (800 mg BIA 5-1058)
Each subject was orally administered a single oral dose of BIA 5-1058 on D1 (dosing day) on three different occasions (Period 1, Period 2 and Period 3):
Part 2: 800 mg BIA 5-1058 as eight (8) 100 mg tablets in Period 1, 800 mg BIA 5-1058 as eight (8) 100 mg tablets in Period 2, and 800 mg BIA 5-1058 as eight (8) 100 mg tablets in Period 3.
干预措施: BIA 5-1058 (Drug)
PART 3 (1200 mg BIA 5-1058)
Each subject was orally administered a single oral dose of BIA 5-1058 on D1 (dosing day) on three different occasions (Period 1, Period 2 and Period 3):
Part 3: 1200 mg BIA 5-1058 as twelve (12) 100 mg tablets in Period 1, 1200 mg BIA 5-1058 as twelve (12) 100 mg tablets in Period 2, and 1200 mg BIA 5-1058 as twelve (12) 100 mg tablets in Period 3.
干预措施: BIA 5-1058 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 9 weeks
In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose
Area under the plasma concentration-time curve (AUC)
时间窗: Up to 9 weeks
In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose
Area under the plasma concentration-time curve (AUC) from time zero to the last sampling time at which the drug concentration was at or above the lower limit of quantification (AUC0-last)
时间窗: Up to 9 weeks
In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose
Time of occurrence of Cmax (tmax)
时间窗: Up to 9 weeks
In all treatment periods, blood samples were taken at the following times: before BIA 5-1058 dosing, and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60 and 72 h post-dose
次要结局
未报告次要终点