An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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)
研究概览
简要总结
The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.
详细描述
This is an open-label, randomised, two arm, 3 period, fixed sequence study in healthy participants.
The study will include two parallel, independent arms with one arm evaluating oral administration of AZD4144 and the other evaluating AZD4144 administered as an intravenous (IV) infusion.
Each study arm will comprise of:
- A screening period of up to 28 days.
- Three treatment periods during which participants will receive AZD4144 alone, itraconazole alone, and AZD4144 in combination with itraconazole.
- A final follow-up visit.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Healthy male and/or female participants with suitable veins for cannulation or repeated venipuncture.
- Body mass index (BMI) between 18.0 and 30.0 kg/m², inclusive, and body weight of at least 50 kg.
- Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.
- Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.
排除标准
- Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.
- History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.
- Any clinically important illness, medical/surgical procedure, or trauma.
- Active systemic bacterial, viral, or fungal infection.
- Clinically significant serious active or chronic infections.
- Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.
- Concomitant immunosuppressive, steroid treatment.
- Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.
- Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.
- Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).
研究组 & 干预措施
Arm 1: Oral AZD4144
In Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
干预措施: AZD4144 (Drug)
Arm 1: Oral AZD4144
In Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
干预措施: Itraconazole (Drug)
Arm 2: IV Infusion AZD4144
In Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
干预措施: AZD4144 (Drug)
Arm 2: IV Infusion AZD4144
In Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under concentration time curve from time 0 to infinity (AUCinf)
时间窗: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (AUCinf) of AZD4144
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
时间窗: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (AUClast) of AZD4144
Maximum observed drug concentration (Cmax)
时间窗: Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16
To assess the effect of itraconazole on the PK (Cmax) of AZD4144
次要结局
- Total body clearance (CL)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
- Apparent total body clearance (CL/F)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
- Volume of distribution during the terminal phase (Vz)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
- Apparent volume of distribution based on the terminal phase (Vz/F)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
- Terminal elimination half life (t½λz)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
- Time to reach maximum observed concentration (tmax)(Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07685600
- 其他研究编号
- D9440C00006
日期
- 首次提交
- (3个月前)
- 首次发布
- (2个月前)
- 主要完成日期
- (27天后)
- 研究完成日期
- (27天后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.