jRCT2080225328暂停1 期
Safety, tolerability and pharmacokinetics of single rising oral doses of BI 894416 versus placebo in healthy male Japanese subjects (single-blind, randomized, placebo-controlled within dose group)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- This single rising dose trial is designed as single-blind, randomised, and placebo-controlled within dose groups. It is planned to include a total of 24 healthy male subjects in the trial. The subjects will be assigned to 3 groups consisting of 8 subjects per group; the groups will be dosed sequentially. Within each dose group, 6 subjects will receive BI 894416 and 2 will receive placebo. Only one dose is tested within each dose group.
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •1.Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a medical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- •2.Japanese ethnicity, according to the following criteria:
- •born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- •3.Age of 20 to 45 years (inclusive) at screening
- •4.BMI of 18.5 to 25.0 kg/m2 (inclusive) at screening
- •5.Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation
- •6.Male subjects with WOCBP partner who are willing to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 90 days thereafter.
排除标准
- •1.Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •2.Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •3.Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •4.Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •5.Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •6.Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication, except appendectomy or simple hernia repair
- •7.Diseases of the central nervous system, including but not limited to, any kind of seizures or stroke, and other relevant neurological or psychiatric disorders
- •8.History of relevant orthostatic hypotension, fainting spells, or blackouts
- •9.Chronic or relevant acute infections
- •10.History of relevant allergy or hypersensitivity, including allergy to the trial medication or its excipients
- •11.Use of drugs within 30 d of planned administration of trial medication that might reasonably influence the results of the trial, including drugs that cause QT/QTc interval prolongation
- •12.Intake of an investigational drug in another clinical trial within 60 d of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
- •13.Smoker, unless the subject quit smoking for at least 12 months prior to first planned administration of trial medication
- •14.Inability to refrain from smoking during trial
- •15.Alcohol abuse, i.e. consumption of more than 30 g per day
- •16.Drug abuse or positive drug screening
- •17.Blood donation of more than 400 mL within 12 weeks, or 200 mL within 30 d, or plasma donation within 2 weeks prior to administration, or intended blood donation during the trial
- •18.Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
- •19.Inability to comply with the dietary regimen of the trial site
- •20.A marked baseline prolongation of QT/QTc interval, such as QTc intervals that are repeatedly greater than 450 ms, or any other relevant ECG finding at screening
- •21.A history of additional risk factors for Torsade de Pointes, such as heart failure, hypokalaemia, or family history of Long QT Syndrome
- •22.Subject is assessed by the investigator as unsuitable for inclusion, because, for instance, the subject is not considered able to understand and comply with trial requirements, or has a condition that would not allow safe participation in the trial
- •23.History of disease that affects the present situation
- •In addition, the following trial-specific exclusion criteria apply:
- •24.History of relevant neurological disorder affecting the peripheral or central nervous system, including, but not limited to, stroke, epilepsy, inflammatory or atrophic diseases affecting the nervous system, cluster headache or any cancer of the nervous system*
- •25.History of immunological disease except allergy not relevant to the trial, such as mild hay fever or dust mite allergy, and except asthma in childhood or adolescence
- •26.History of cancer, except successfully treated basal cell carcinoma
- •27.Use of any drug that could reasonably inhibit platelet aggregation or coagulation, e.g. acetylsalicylic acid, within 10 d prior to administration of trial medication, or planned use during the trial or within 7 d after last dose of trial medication
结局指标
主要结局
-
safety The percentage (%) of subjects with drug related adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A study in healthy Japanese men to test how different doses of BI 1323495 are tolerated and how itraconazole influences the amount of BI 1323495 in the bloodjRCT2071200056Nippon Boehringer Ingelheim Co., Ltd.74
已完成
不适用
A study in healthy Japanese men to test how well different doses of BI 1291583 are toleratedjRCT2071210111Nippon Boehringer Ingelheim Co., Ltd.36
进行中（未招募）
不适用
A study in healthy Japanese men to test how well different doses of BI 3006337 are toleratedNon-alcoholic SteatohepatitisjRCT2031230638Boehringer Ingelheim36
尚未招募
不适用
A study in healthy Japanese men to test how well different doses of BI 764198 are toleratedjRCT2071200055Boehringer Ingelheim44
已完成
不适用
A study in healthy Japanese men to test how well different doses
of BI 1569912 are toleratedjRCT2071210037Nippon Boehringer Ingelheim Co., Ltd.44