A Phase I, Randomized, Single-dose, Crossover, 2-Period, Open-Label Study to Assess the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- Maximum observed drug concentration (Cmax)
研究概览
简要总结
The purpose of this study is to measure the pharmacokinetics (PK-how the body processes the study drug) of elecoglipron in healthy participants when taken by mouth as different formulations.
详细描述
This is a phase I, open-label, randomized, 2-period crossover study with 4-cohorts. All 4 cohorts are independent and non-sequential parts in this study. Each cohort will evaluate 2 formulations (test formulation and reference formulation) of elecoglipron across 2 study treatment periods. Participants within each cohort will be randomized to one of 2 treatment sequences (Test-Reference or Reference-Test).
In total 3 formulations will be evaluated at 2 dose levels each:
- Reference formulation
- Test formulation 1
- Test formulation 2
The study will comprise:
- A Screening Period.
- 2 treatment periods in each cohort - Period 1, and Period 2 during which participants will be admitted to the Clinical Unit and receive a single oral dose of elecoglipron in each period.
- A final Follow-up Visit.
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
- •Healthy participants with suitable veins for cannulation or repeated venipuncture.
- •All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- •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 at screening visit as postmenopausal or have documentation of irreversible surgical sterilization.
- •Sexually active fertile male participants with partners of childbearing potential must adhere to the study specific contraception methods.
- •Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg.
排除标准
- •History of any clinically important disease or disorder.
- •History of acute pancreatitis.
- •History or presence of gastrointestinal (GI) or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
- •Any clinically important illness, medical/surgical procedure, or trauma.
- •Participants who have previously received elecoglipron within the last 3 months.
研究组 & 干预措施
Cohort 1-Treatment Sequence A
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose A (Drug)
Cohort 2 - Treatment Sequence C
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose B (Drug)
Cohort 2 - Treatment Sequence C
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose B) in Period 2.
干预措施: Elecoglipron Test formulation 1 Dose B (Drug)
Cohort 1-Treatment Sequence A
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 1 (Dose A) in Period 2.
干预措施: Elecoglipron Test formulation 1 Dose A (Drug)
Cohort 1 - Treatment Sequence B
Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose A (Drug)
Cohort 1 - Treatment Sequence B
Participant will receive a single dose of elecoglipron test formulation 1 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
干预措施: Elecoglipron Test formulation 1 Dose A (Drug)
Cohort 2 - Treatment Sequence D
Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
干预措施: Elecoglipron Test formulation 1 Dose B (Drug)
Cohort 4 - Treatment Sequence G
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose B (Drug)
Cohort 3 - Treatment Sequence F
Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose A (Drug)
Cohort 2 - Treatment Sequence D
Participant will receive a single dose of elecoglipron test formulation 1 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose B (Drug)
Cohort 4 - Treatment Sequence H
Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
干预措施: Elecoglipron Test formulation 2 Dose B (Drug)
Cohort 3 - Treatment Sequence E
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose A (Drug)
Cohort 4 - Treatment Sequence G
Participant will receive a single dose of elecoglipron reference formulation (Dose B) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose B) in Period 2.
干预措施: Elecoglipron Test formulation 2 Dose B (Drug)
Cohort 4 - Treatment Sequence H
Participant will receive a single dose of elecoglipron test formulation 2 (Dose B) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose B) in Period 2.
干预措施: Elecoglipron Reference Formulation Dose B (Drug)
Cohort 3 - Treatment Sequence E
Participant will receive a single dose of elecoglipron reference formulation (Dose A) in Period 1 followed by a single dose of elecoglipron test formulation 2 (Dose A) in Period 2.
干预措施: Elecoglipron Test formulation 2 Dose A (Drug)
Cohort 3 - Treatment Sequence F
Participant will receive a single dose of elecoglipron test formulation 2 (Dose A) in Period 1 followed by a single dose of elecoglipron reference formulation (Dose A) in Period 2.
干预措施: Elecoglipron Test formulation 2 Dose A (Drug)
结局指标
主要结局
Maximum observed drug concentration (Cmax)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Area under concentration-time curve from time 0 to infinity (AUCinf)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Time to reach maximum observed concentration (tmax)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination rate constant (λz)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Terminal elimination half-life (t1/2λz)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent total body clearance (CL/F)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Apparent volume of distribution based on the terminal phase (Vz/F)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUCinf (R AUCinf)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on AUClast (R AUClast)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
Ratio of elecoglipron (test formulation) to elecoglipron (reference formulation) based on Cmax (R Cmax)
时间窗: At pre-defined intervals from Day 1 to Day 15
To evaluate the PK of different formulations of elecoglipron following single oral administration in healthy participants.
次要结局
- Number of participants with adverse events (AEs)(From screening (Day -28) up to follow-up visit (Day 18-Day 22))