An Open-Label, Randomized, Four-Treatment, Four-Period, Single-Dose Crossover Study in Healthy Participants to Assess the Relative Bioavailability of AZD5004 in Three Solid Oral Formulations (F1, F3, F4)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 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 assess the relative bioavailability of a single dose AZD5004 in healthy participants, among 3 different oral tablet formulations.
详细描述
This study will be an open-label, randomized, 4-period, 4-treatment, single-dose crossover study in healthy participants.
Participants will receive one single dose of AZD5004 at the beginning of each of the four Treatment Periods, and a total of 4 doses of AZD5004. Three different formulations (F1, F3, and F4) will be used across the Treatment Periods.
The study comprises of total four treatment periods.
- A Screening Period of maximum 27 days. Four Treatment Periods of 7 days each.
- Treatment Period 1 (Day -1 to Day 6)
- Treatment Period 2 (Day 7 to Day 13)
- Treatment Period 3 (Day 14 to Day 20)
- Treatment Period 4 (Day 21 to Day 27)
- A final Follow-up Visit within 7 to 10 days after the last study intervention administration (Day 22 of Treatment Period 4).
The treatments are as follows:
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 male and female participants with suitable veins for cannulation or repeated venipuncture.
- •Female participants:
- •Female(s) of childbearing potential: If heterosexually active must agree to use an approved method of highly effective contraception.
- •Female(s) not of childbearing potential
- •Male participants:
- •Condom use is required for the duration of the clinical study.
- •Additional contraception must be used for the sexual partners of male study participants throughout the clinical study.
- •Have a Body Mass Index (BMI) ≥ 23 kg/m2 and not exceeding 35 kg/m2 inclusive (at the time of Screening) and weigh at least 60 kg.
排除标准
- •History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study
- •History of acute pancreatitis (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy), chronic pancreatitis, gallstones, or elevation in serum lipase/pancreatic amylase.
- •Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract (including bariatric surgery).
- •Any clinically important illness, medical/surgical procedure, or trauma.
- •Any laboratory values with the deviations specified in protocol and clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- •Any positive result at Screening for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) or Human immunodeficiency Virus (HIV).
- •Abnormal vital signs, after 10 minutes supine rest, at Screening and/or admission to the Clinical Unit.
- •Serum triglyceride concentrations above 1000 mg/dL (11 mmol/L).
- •Basal calcitonin level > 50 ng/L or pg/mL at Screening or history/family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN), type
- •Known or suspected history of alcohol or drug abuse or excessive intake of alcohol
- •Positive screen for drugs of abuse, or alcohol or cotinine (nicotine).
- •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 AZD
- •Excessive intake of caffeine-containing drinks or food
- •History of psychosis or bipolar disorder and major depressive disorder.
- •History of suicide attempt or history of suicidal ideation within the past year.
研究组 & 干预措施
Treatment Sequence A
Participants will receive single dose of AZD5004 on Day 1 in F1 (fasted) (Treatment period 1), on Day 8 in F4 (fasted) (Treatment period 2), on Day 15 in F4(fed) (Treatment Period 3) followed by on Day 22 in F3 (fasted) (Treatment Period 4) respectively.
干预措施: AZD5004 (Drug)
Treatment Sequence B
Partcipants will receive single dose of AZD5004 on Day 1 in F4 (fasted) (Treatment Period 1), on Day 8 in F4 (fed) (Treatment Period 2), on Day 15 in F3 (fasted) (Treatment Period 3) followed by on Day 22 in F1 (fasted) (Treatment Period 4) respectively.
干预措施: AZD5004 (Drug)
Treatment Sequence C
Participants will receive single dose of AZD5004 on Day 1 in F4 (fed) (Treatment Period 1), on Day 8 in F3 (fasted) (Treatment Period 2, on Day 15 in F1 (fasted) (Treatment Period 3 followed by on Day 22 in F4 (fasted) (Treatment Period 4) respectively.
干预措施: AZD5004 (Drug)
Treatment Sequence D
Participants will receive single dose of AZD5004 on Day 1 in F3 (fasted) (Treatment Period 1), Day 8 in F1 (fasted) (Treatment Period 2), on Day 15 in F4 (fasted) (Treatment Period 3) followed by Day 22 in F4 (fed) (Treatment Period 4) respectively.
干预措施: AZD5004 (Drug)
结局指标
主要结局
Area under concentration-time curve from time 0 to infinity (AUCinf)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Maximum observed drug concentration (Cmax)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Time to reach maximum observed concentration (tmax)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Half-life (t½)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
Apparent total body clearance (CL/F)
时间窗: Day 1-6, Day 8-13, Day 15-20 and Day 22-27
To assess the relative bioavailability of AZD5004 in 3 different solid oral formulations (F1, F3, F4)
次要结局
- Area under concentration-time curve from time 0 to infinity (AUCinf)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Maximum observed drug concentration (Cmax)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Time to reach maximum observed concentration (tmax)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Half-life (t½)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Apparent total body clearance (CL/F)(Day 1-6, Day 8-13, Day 15-20 and Day 22-27)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Screening (Day -28 to Day -2) up to Follow-up (Day 29 to Day 32))