An Open-label, Randomised, 2-arm, 3-period, 6-treatment Single-dose, Crossover Study Comparing the Pharmacokinetics of 2 Different Formulations of AZD4144, and Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
研究概览
简要总结
The main aim of this study to compare the pharmacokinetics (PK) of two formulations of AZD4144 and assess the effect of food and omeprazole on PK of AZD4144 in healthy participants.
详细描述
This is an open-label, randomized, single-dose, crossover Phase I study.
The study will comprise:
- A Screening Period of 28 days.
- Three Residential Periods
- A final Follow-up period within 7 to 10 days after the last dose of study drug. There will be a minimum washout period of 7 days between each AZD4144 dose.
This study includes the following 2 arms:
Arm 1 consists of 3 treatments:
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed the informed consent form before any study-related procedure.
- •Healthy male and female participants with suitable veins for cannulation or repeated venipuncture.
- •Negative pregnancy test for females at screening, first admission, and follow-up.
- •Females of childbearing potential must use highly effective contraception from first dose until 3 months after last dose.
- •Non-childbearing potential females must meet postmenopausal or surgical sterilization criteria.
- •Sexually active fertile males must use contraception from first dose until 3 months after last dose.
- •Body Mass Index (BMI) between 18-32 kg/m2 and weight ≥45 kg at screening and first admission.
排除标准
- •History of any clinically important disease or disorder that may put the participant at risk or influence study results.
- •History or presence of gastrointestinal, hepatic, or renal disease or any condition affecting drug absorption, distribution, metabolism, or excretion.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of randomization.
- •Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing or presence of fever within 14 days prior to dosing.
- •Clinically significant serious active and chronic infections within 60 days prior to randomization.
- •Any history or evidence of tuberculosis (TB) (active or latent) using TB-QuantiFERON tests during screening.
- •Clinical signs and symptoms consistent with coronavirus disease 2019 (COVID-19).
- •Known history of primary immunodeficiency or an underlying condition that predisposes to infection.
- •Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV).
- •Plasma donation within one month of the screening visit or any blood donation/blood loss > 500 mL during the 3 months prior to the screening visit.
- •Participants who have previously received AZD4144.
研究组 & 干预措施
Arm 1: AZD4144
Participants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions.
干预措施: AZD4144 (Drug)
Arm 2: AZD4144 + Omeprazole
Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F).
干预措施: AZD4144 (Drug)
Arm 2: AZD4144 + Omeprazole
Participants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F).
干预措施: Omeprazole (Drug)
结局指标
主要结局
Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
时间窗: Days 1-4, Days 8-11 and Days 15-18
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144
时间窗: Days 1-4, Days 8-11 and Days 15-18
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
Maximum observed drug concentration (Cmax) of AZD4144
时间窗: Days 1-4, Days 8-11 and Days 15-18
1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.
次要结局
- Number of participants with serious AEs(From Screening (Day -28 to Day -2) to Day 25)
- Number of participants with adverse events (AEs)(From Day 1 to Day 25)