A Phase I, Single-Centre, Open, Randomized, Two-Way Crossover Study to Evaluate the Pharmacokinetics of the Extended-Release Test Formulation of AZD0837 Compared to the Extended-Release AZD0837 Reference Formulation After Repeated Dosing in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.
研究概览
简要总结
The aims of this study are to evaluate the pharmacokinetics, safety and tolerability of the oral doses of the extended-release test- and reference formulations of AZD0837 in healthy volunteers both in fasting and fed conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy subject aged between 18 to 45 years inclusive
- •Body mass index (BMI) between 19 to 30 kg/m2 inclusive
- •Body weight between 50 to 100 kg inclusive
- •Women must be either post-menopausal, permanently sterilised or, if of childbearing potential, must have a negative pregnancy test before intake of study medication and use a reliable form of contraception before and during participation in the study.
排除标准
- •Significant illness (including ongoing or history of liver disease), trauma or surgical procedures from 2 weeks before the pre-entry visit until the first administration of Investigational Product
- •Clinical significant abnormalities in clinical chemistry, haematology or urinalysis result including positive result on screening tests for serum hepatitis B surface antigen, hepatitis C antibody or HIV or positive F-Hb result pre-entry
- •History of bleeding disturbance (including extensive menstrual bleedings) or thrombotic disorder
- •Clinically significant medical history, as judged by the investigator, including psychiatric disorders or severe allergies.
研究组 & 干预措施
HAB
AZD0837 test- (in session 1) and reference- (in session 2) formulation with heavy breakfast
干预措施: AZD0837 (Drug)
HBA
AZD0837 reference- (in session 1) and test- (in session 2) formulation with heavy breakfast
干预措施: AZD0837 (Drug)
LAB
AZD0837 test- (in session 1) and reference- (in session 2) formulation with light breakfast
干预措施: AZD0837 (Drug)
LBA
AZD0837 reference- (in session 1) and test- (in session 2) formulation with light breakfast
干预措施: AZD0837 (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of AZD0837 and the active metabolite AR-H067637XX for the extended-release test formulation of AZD0837 compared to the ER reference formulation.
时间窗: Intense PK-sampling during 5 pre- defined study days for PK profiling. In 2 of the study days the subjects will have a breakfast before intake of the Investigational Product.
次要结局
- To evaluate the PK of the intermediate metabolite AR-H069927XX(Since the metbolite will be evaluated from the AZD0837-samples the time frame is the same as above.)
- Safety variables (ECG, pulse, blood pressure, safety lab, physical examination, adverse events)(ECG & physical examination at start and end of study. Pulse and blood pressure predose day 1 and every day 2 h post dose. Adverse events collected during the whole study. Safety lab at a few timepoints but APTT will be checked on 4 h post dose on day 1.)
- Measurement of plasma concentrations of 4 beta-hydroxycholesterol to investigate whether AZD0837 affects the level of CYP3A4(Once predose on day 1, session 1 and once predose on day 5, session 2)