NCT05354453已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1839100 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
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
- 104
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
This trial starts the clinical development of BI 1839100. Effects of single rising doses of BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further development in patients with pulmonary fibrosis.
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
- Double (Participant, Outcomes Assessor)
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 subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 45 years (inclusive)
- •Body mass index (BMI) of 18.5 to 31.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Male subjects who meet any of the following criteria for a highly effective contraception from the first administration of trial medication until 90 days after trial completion:
- •Willing to use a medically accepted method of contraception. Acceptable methods of contraception for use by male subjects include sexual abstinence, a vasectomy performed at least 1 year prior to dosing, and barrier contraception (condom)
- •Subjects who are not vasectomised or sexually abstinent have to ensure that an additional acceptable method of contraception (in addition to male condom) will be used by his female partner such as intrauterine device (IUD), surgical sterilisation (including hysterectomy), hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 month prior to drug administration or postmenopausal status of female partner (defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •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 45 to 90 bpm (subjects with heart rate values between 45 and 50 bpm may only be enrolled in case they have a normal thyroid function, no clinical symptoms associated with the bradycardia and no apparent signs of other diseases causing bradycardia such as hypothyroidism or heart conduction abnormalities)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or 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 Further exclusion criteria apply.
研究组 & 干预措施
SRD Part
Experimental
Single-rising dose (SRD)
干预措施: BI 1839100 (Drug)
SRD Part: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Skin Challenge Part
Experimental
干预措施: BI 1839100 (Drug)
Skin Challenge Part
Experimental
干预措施: allyl isothiocyanate (AITC) (Drug)
Skin Challenge Part: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Skin Challenge Part: Placebo
Placebo Comparator
干预措施: allyl isothiocyanate (AITC) (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to 10 days
次要结局
- Time from dosing to maximum measured concentration of BI 1839100 in plasma (tmax)(up to 4 days)
- Area under the concentration-time curve of BI 1839100 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 4 days)
- Maximum measured concentration of BI 1839100 in plasma (Cmax)(up to 4 days)
研究者
研究点 (1)
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