NCT03210272已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1358894 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1358894 (Open-label, Randomised, Two-way Cross-over)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Drug- Related Adverse Event
研究概览
简要总结
The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), including dose proportionality of BI 1358894 after single dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- •Age of 18 to 45 years (incl.)
- •BMI of 18.5 to 29.9 kg/m2 (incl.)
- •Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- •Willingness to comply with contraception requirements. Subjects who are sexually active, must use, with their female partner, adequate contraception throughout the study and until one month after the last administration of trial medication. Adequate methods are:
- •Sexual abstinence or
- •A vasectomy performed at least 1 year prior to screening in combination with a barrier method (condom) or
- •Surgical sterilisation (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subjects female partner or
- •The use of condoms, if the female partner uses in addition an adequate contraception method, e.g., intrauterine device (IUD), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide)
- •Unprotected sexual intercourse with a pregnant female partner is not allowed throughout the study and until one month after the last administration of trial medication
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) is deviating from normal
- •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
- •C-Reactive Protein > ULN, erythrocyte sedimentation rate (ESR) ≥ 15 millimeters/hour, liver and kidney parameter above ULN, other laboratory values outside the reference range the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease judged as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Chronic or relevant acute infections
- •History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- •Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (incl. QT/QTc interval prolongation)
- •Participation in another trial where an investigational drug has been administered within 60 days prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
- •Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
- •Inability to refrain from smoking on specified trial days
- •Alcohol abuse (consumption of more 30 g per day for males)
- •Drug abuse as per investigator judgment or positive drug screening
- •Blood donation of more than 100 mL within 30 days prior to administration of trial medication or intended donation during the trial
- •Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- •Inability to comply with dietary regimen of trial site
- •A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms in males) or any other relevant ECG finding at screening
- •A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- •Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
- •Any lifetime history of suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
- •Any suicidal ideation of type 2 to 5 on the C-SSRS in the past 12 months (i.e. active suicidal thought, active suicidal thought with method, active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
研究组 & 干预措施
Single rising dose part
Experimental
Group of healthy male volunteers receive rising single doses of BI 1358894
干预措施: Placebo (Drug)
Single rising dose part
Experimental
Group of healthy male volunteers receive rising single doses of BI 1358894
干预措施: BI 1358894 (Drug)
Food effect part
Experimental
Group of healthy male volunteers receive single doses of BI 1358894 with and without food
干预措施: BI 1358894 (Test) (Drug)
Food effect part
Experimental
Group of healthy male volunteers receive single doses of BI 1358894 with and without food
干预措施: BI 1358894 (Reference) (Drug)
结局指标
主要结局
Percentage of Subjects With Drug- Related Adverse Event
时间窗: From start of treatment until end of trial. Up to 14 days for single rising dose part under fasting condition (3mg to 200mg) and the food effect part and up to 33 days for the single rising dose part under fed conditions (200mg fed dose group)
Percentage of subjects with drug-related adverse events
次要结局
- Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 Extrapolated to Infinity(Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration)
- Area Under the Concentration-time Curve of the Analyte BI1358894 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Time Point(Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration)
- Maximum Measured Concentration of the Analyte BI 1358894 in Plasma(Within 2 hours (h) before and 0.167h, 0.333h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 16h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 192h after drug administration)
研究者
研究点 (1)
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