An Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of AZD4954 and Vice Versa in Healthy Adults.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954
研究概览
简要总结
The purpose this study is to measure the impact of laroprovstat (AZD0780) on the pharmacokinetics (PK) of AZD4954 and the impact of AZD4954 on the PK of laroprovstat in healthy male and female participants.
详细描述
This is an open-label, fixed-sequence, 2 period and 2 cohort study in healthy participants.
Each participant in each cohort will receive treatments in a fixed order during the 2 treatment periods as follows:
- Cohort 1: Treatment A followed by Treatment C.
- Cohort 2: Treatment B followed by Treatment C.
The following treatments will be given during the study:
- Treatment A: single dose of AZD4954 alone.
- Treatment B: single dose of laroprovstat alone.
- Treatment C: single doses of laroprovstat + AZD4954.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •All females must have a negative pregnancy test at the Screening Visit.
- •Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- •Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- •Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- •Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
排除标准
- •History of any clinically important disease or disorder.
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- •Participants with known bleeding or coagulation disorders.
- •Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.
- •Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- •Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead electrocardiogram at screening.
- •Participants who are current smokers or have used any tobacco or nicotine-containing products (including e-cigarettes) within 3 months prior to screening; known or suspected history of alcohol or drug abuse; positive screen for drugs of abuse, alcohol, or cotinine at screening or on each admission to the Clinical Unit.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs of a similar chemical structure or class to AZD4954 or laroprovstat.
- •Participants who have previously received AZD
- •Treatment with any lipid-lowering therapy or laroprovstat within the 3 months prior to the Screening Visit.
研究组 & 干预措施
Cohort 2: Treatment Sequence BC
Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).
干预措施: Laroprovstat (Drug)
Cohort 1: Treatment Sequence AC
Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).
干预措施: Laroprovstat (Drug)
Cohort 1: Treatment Sequence AC
Participant will receive single dose of AZD4954 alone (Treatment A) followed by single doses of laroprovstat+AZD4954 (Treatment C).
干预措施: AZD4954 (Drug)
Cohort 2: Treatment Sequence BC
Participant will receive single dose of laroprovstat alone (Treatment B) followed by single doses of laroprovstat+AZD4954 (Treatment C).
干预措施: AZD4954 (Drug)
结局指标
主要结局
Area under concentration time curve from time 0 to infinity (AUCinf) of AZD4954
时间窗: Cohort 1: Day 1 to Day 41
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
Maximum observed drug concentration (Cmax) of AZD4954
时间窗: Cohort 1: Day 1 to Day 41
To assess the effect of a single dose of oral laroprovstat on the PK of a single dose of oral AZD4954 in healthy participants.
AUCinf of laroprovstat
时间窗: Cohort 2: Day 1 to Day 25
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
Cmax of laroprovstat
时间窗: Cohort 2: Day 1 to Day 25
To assess the effect of a single dose of oral AZD4954 on the PK of a single dose of oral laroprovstat in healthy participants.
次要结局
- Area under concentration curve from time 0 to the last quantifiable concentration (AUClast) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Apparent total body clearance (CL/F) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Terminal elimination half-life (t½λz) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Time to reach maximum observed concentration (tmax) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Time of last quantifiable concentration (tlast) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Time delay between drug administration and the first observed concentration (tlag) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4954(Cohort 1: Day 1 to Day 41; Cohort 2: Day 11 to Day 31)
- AUClast of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- CL/F of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- t½λz of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- tmax of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- tlast of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- tlag of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- Vz/F of laroprovstat(Cohort 1: Day 21 to Day 35; Cohort 2: Day 1 to Day 25)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Cohort 1: Up to Day 83; Cohort 2: Up to Day 73)