NCT05728671尚未招募1 期
An Open-Label, Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015 in Healthy Male Subjects
Initiator Pharma0 个研究点目标入组 12 人开始时间: 2023年2月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- AUC
研究概览
简要总结
The study's primary objective is to determine the bioavailability of two solid formulations of IP2015 compared to a liquid formulation of IP2015 in healthy male subjects
详细描述
It is planned to include 12 subjects. Each subject will take part in three treatment periods, in which they will receive a single dose of IP2015 liquid and then to different IP2015 solid formulations, respectively, in each treatment period. Overall, each subject will receive each treatment once only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive.
- •Subject is ≥50 kg.
- •Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.
排除标准
- •Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
- •Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic or renal disorder).
- •Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
研究组 & 干预措施
IP2015_PO release form 1
Experimental
Test formulation 1
干预措施: IP2015 (Drug)
IP2015_PO release form 2
Experimental
Test formulation 2
干预措施: IP2015 (Drug)
IP2015_PO release form 3
Experimental
Test formulation 3
干预措施: IP2015 (Drug)
结局指标
主要结局
AUC
时间窗: 72 hours
Pharmacokinetics
Cmax
时间窗: 72 hours
Pharmacokinetics
Tmax
时间窗: 72 hours
Pharmacokinetics
次要结局
未报告次要终点
研究者
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