NCT00906256已完成1 期
A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects
Arrow Therapeutics1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年4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
- 16
- 试验地点
- 1
- 主要终点
- To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects.
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetic profile of oral doses of AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as safety and tolerability.
详细描述
OBJECTIVES: Primary
- To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects
- To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects
- To assess the safety and tolerability profiles of oral daily doses of AZD7295 capsules in healthy subjects TYPE AND DESIGN: Part A A phase I, single-centre, double-blind, randomised, placebo-controlled, crossover, food effect study in healthy subjects
Part B A phase I, single-centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy subjects
NUMBER OF SUBJECTS: 16 subjects will take part in a total of 4 treatment periods.
SUBJECT CHARACTERISTICS: Healthy males and females of non-child bearing potential aged 18 to 65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or healthy females of non-child bearing potential
- •Aged 18-65 years;
- •Body Mass Index (BMI) of 18-32kg/m2;
- •Normal electrocardiograms (ECGs) or with clinically insignificant abnormalities in the opinion of the Investigator;
- •Normal vital signs or with clinically insignificant abnormalities in the opinion of the Investigator;
- •Clinically normal physical findings and safety laboratory values at the time of the screening visit, as judged by the Investigator;
- •Must be willing and able to participate in the whole study and must provide written informed consent.
排除标准
- •Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
- •Subjects who have previously been enrolled in this study;
- •A past or current disease, which as judged by the Investigator, could affect the subject's participation in or the outcome of the study. These diseases include, but are not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease;
- •Subjects who have ever sought advice from or been referred to a GP or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
- •Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;);
- •Positive drugs of abuse test result (Appendix 1, Section 20);
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
- •Smoking of more than 10 cigarettes per day and the inability to refrain from smoking during confinement;
- •Females of child bearing potential, as detailed in Section 9.4;
- •Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Appendix 1, Section 20);
- •History of adverse reaction or allergy to study drug or its excipients. If the subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
- •Subjects with known present or past medical history, or family history (as far as known by the subject) of any of the following cardiovascular findings:
- •2nd degree AV-block (type II) or 3rd degree AV-block and/or other relevant arrhythmias
- •Prolonged QT-interval syndrome or other cardiac conduction disorder QTc > 450 ms
- •PR interval outside range of 120 - 220 ms
- •Evidence of clinically significant T wave abnormalities
- •Donation of blood within the previous three months;
- •Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, thorough blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
- •Positive HBV, HCV or HIV results;
- •Excessive use of caffeine (more than five cups of coffee or equivalent per day);
- •Subjects receiving prohibited medication as described in Section 9.5;
- •Subjects with planned surgery, dental procedure or hospitalisation during the study;
- •Failure to satisfy the PI of fitness to participate for any other reason.
研究组 & 干预措施
AZD7295
Active Comparator
AZD7295
干预措施: AZD7295 (Drug)
Placebo capsule
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects.
时间窗: PK samples at pre-dose, 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 12.0h and 24.0h post dose.
To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects
时间窗: 1st two treatment days of study
To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects.
时间窗: at each dosing day
次要结局
未报告次要终点
研究者
研究点 (1)
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