A Fixed-sequence, Open-label Study to Assess the Effect of AZD0780 on the Pharmacokinetics of Metformin in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 14
- 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 this study is to determine how the experimental medication AZD0780 impacts the pharmacokinetics (PK) of metformin, a common medication used to treat type 2 diabetes mellitus, when given together in healthy participants.
详细描述
This is an open-label, 2-period, fixed-sequence study in healthy participants (males and females), performed at a single Clinical Unit. The study will assess the PK of metformin when administered alone and in combination with a single dose of AZD0780.
The study will comprise:
- A Screening Period of maximum 28 days.
- Two Treatment Periods (Day -1 to Day 7 and Day 8 to Day 10) during which participants will be resident at the Clinical Unit and will receive the study intervention.
- A final Follow-up Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Have a body mass index (BMI) between 18 and 35 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at the Screening Visit.
- •Participants agree to follow study specific contraceptive requirements.
- •Have suitable veins for cannulation or repeated venipuncture.
排除标准
- •History of any clinically important disease or disorder which may put the participant at risk because of participation in the study or influence the results.
- •Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to metformin or AZD
- •Treatment with any lipid lowering therapy or AZD0780 within the 3 months prior to the Screening Visit.
- •Treatment with drugs for reduction or inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9) within the last 12 months prior to the Screening Visit (approved or investigational and apart from AZD0780).
- •Current or previous administration of inclisiran.
研究组 & 干预措施
Metformin/Metformin + AZD0780
Participants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8.
干预措施: AZD0780 (Drug)
Metformin/Metformin + AZD0780
Participants will receive a single dose of metformin on Day 1 in Treatment Period 1 followed by a washout period of 7 days. In Treatment Period 2, participants will receive a single dose of AZD0780 followed by a single dose of metformin on Day 8.
干预措施: Metformin (Drug)
结局指标
主要结局
Area under concentration time curve from time 0 to infinity (AUCinf)
时间窗: Days 1 to 3 and Days 8 to 10
To assess the effect of AZD0780 on the PK of metformin.
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
时间窗: Days 1 to 3 and Days 8 to 10
To assess the effect of AZD0780 on the PK of metformin.
Maximum observed drug concentration (Cmax)
时间窗: Days 1 to 3 and Days 8 to 10
To assess the effect of AZD0780 on the PK of metformin.
次要结局
- Number of participants with Adverse Events (AEs)(Day 1 until Follow-up visit or early discontinuation (Up to Day 18))
- Apparent total body clearance (CL/F)(Days 1 to 3 and Days 8 to 10)
- Apparent volume of distribution based on the terminal phase (Vz/F)(Days 1 to 3 and Days 8 to 10)
- Terminal elimination half life (t½λz)(Days 1 to 3 and Days 8 to 10)
- Time to reach maximum observed concentration (tmax)(Days 1 to 3 and Days 8 to 10)
- Renal clearance (CLR)(Days 1 to 3 and Days 8 to 10)
- Amount of unchanged drug excreted into urine (Ae)(Days 1 to 3 and Days 8 to 10)
- Percentage of dose excreted unchanged in urine (fe)(Days 1 to 3 and Days 8 to 10)