A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
- •Healthy male and female volunteers. Females must be of non childbearing potential
排除标准
- •Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
- •History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
研究组 & 干预措施
Placebo to AZD5847
Placebo
干预措施: Placebo to AZD5847 (Drug)
AZD5847 oral suspension
Active
干预措施: AZD5847 (Drug)
结局指标
主要结局
Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals
时间窗: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.
次要结局
- To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.(Samples taken during the residential period at defined timepoints pre-dose and post-dose.)
- To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847(Samples taken during the residential period at defined timepoints pre-dose and post-dose)