An Open-Label, Randomized, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation (F1) Compared to New Tablet Formulation (F2) of ECC5004 and Food Effects on F1 and F2 of ECC5004 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- ECC5004 PK parameters: AUC0-tlast
研究概览
简要总结
This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants
详细描述
Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. In the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2. In the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female participants of non-childbearing potential
- •Age of 18 to 65 years
- •BMI of 18.0 to 32.0 kg/m2
- •Female participants who are postmenopausal, confirmed by FSH test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence
- •Male participants agree to use contraception, or agree to practice true abstinence
- •No clinically significant findings in physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history
- •Able to understand and sign and date informed consent
排除标准
- •Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study.
- •Concomitant participation in any investigational study of any nature
- •Blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing
- •Serum calcitonin > 20 ng/L
- •Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
- •Individual or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or suspected MTC
- •History of pancreatitis
- •Significant allergic reaction to active ingredients or excipients of the study drug
- •Any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the Investigator would prevent the participants from participating in the study.
研究组 & 干预措施
Fixed Sequence 1
Participants will receive single dose of ECC5004 F1 at fasted state, followed by F2 at fasted state, F1 at fed state and F2 at fed state in four treatment periods.
干预措施: ECC5004 (Drug)
Fixed Sequence 2
Participants will receive a single dose of ECC5004 F2 at fasted state, followed by F1 at fasted state, F2 at fed state, and F1 at fed state with four treatment periods.
干预措施: ECC5004 (Drug)
结局指标
主要结局
ECC5004 PK parameters: AUC0-tlast
时间窗: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
ECC5004 PK parameters: tmax
时间窗: Up to day 6
Time of the maximum observed plasma concentration
ECC5004 PK parameters: AUC0-inf
时间窗: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
ECC5004 PK parameters: Cmax
时间窗: Up to day 6
Maximum observed plasma concentration
次要结局
- Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations(Up to Day 6)
- ECC5004 PK parameters: tlag(Up to day 6)
- ECC5004 PK parameters: AUC 0-24(Up to day 6)
- ECC5004 PK parameters: t1/2(Up to day 6)
- ECC5004 PK parameters: CL/F(Up to day 6)
- ECC5004 PK parameters: AUC(extr)(Up to day 6)
- ECC5004 PK parameters: AUC0-tau(Up to day 6)