An Open-label, 2-Period, 2-Sequence Cross-over Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Rosuvastatin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Apparent total body clearance (CL/F) of Rosuvastatin
研究概览
简要总结
The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.
详细描述
Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:
Treatment A: single dose of rosuvastatin tablet alone
Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet
The study will comprise:
- A Screening Period of maximum 28 days.
- Two Treatment Periods up to 3 days
- A follow-up period of 10 to 12 days after the last administration of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 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.
- •Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
- •Females must have a negative pregnancy test at screening and must not be lactating
- •Participants with BMI between 18 and 30 kg/m^2, inclusive, and weighing between 50 kg and 100 kg, inclusive
排除标准
- •History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder
- •Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- •Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first vaccination within 30 days prior to randomization and second vaccination within 10 days of screening
- •Confirmed Coronavirus disease 2019 (COVID-19) infection at admission, by Polymerase chain reaction (PCR) test
- •Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening
- •History or presence of severe allergy/hypersensitivity
- •Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening
- •Positive screen for drugs of abuse, alcohol, or cotinine at screening
- •Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug
- •Any clinically significant abnormalities in clinical chemistry, hematology, coagulation, urinalysis results, ECG or vital signs
研究组 & 干预措施
Treatment sequence A-B
Participants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2.
干预措施: AZD0780 (Drug)
Treatment sequence A-B
Participants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2.
干预措施: Rosuvastatin (Drug)
Treatment sequence B-A
Participants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2.
干预措施: AZD0780 (Drug)
Treatment sequence B-A
Participants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Apparent total body clearance (CL/F) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent total body clearance (CL/F) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Maximum observed plasma concentration (Cmax) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Maximum observed plasma concentration (Cmax) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Terminal elimination half-life (t½λz) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of Rosuvastatin
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Time to reach maximum observed concentration (tmax) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780
时间窗: Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose
The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed.
次要结局
- Number of participants with Adverse Events(From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose))