NCT04926246已完成1 期
Formulation Selection and Subsequent Optimization of Oral Formulations of BI 685509 in Healthy Male Subjects (Open-label, Randomized, Single-dose Design Study in up to Three Parts; Trial Part 1: Five-period Crossover; Optional Trial Parts 2 & 3: Fourperiod Crossover)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
The main objective of this trial is to select a formulation and to optimize the identified formulation of BI 685509, if needed.
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 55 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 55 years (inclusive) at the time of signing informed consent
- •Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive) at the time of signing informed consent
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- •Subjects who are sexually active must use with their partner, highly effective contraception from the time of administration of trial medication until 30 days after administration of trial medication. Adequate methods are:
- •Condoms plus use of hormonal contraception by the female partner that started at least 2 months prior to administration of trial medication (e.g., implants, injectables, combined oral or vaginal contraceptives, intrauterine device) or
- •Condoms plus surgical sterilization (vasectomy at least 1 year prior to enrolment) or
- •Condoms plus surgically sterilised partner (including hysterectomy) or
- •Condoms plus intrauterine device or
- •Condoms plus partner of non-childbearing potential (including homosexual men) Subjects are required to use condoms to prevent unintended exposure of the partner (both, male and female) to the study drug via seminal fluid. Male subjects should use a condom throughout the study and for 30 days after last Investigational Medicinal Product (IMP) administration. Alternatively, true abstinence is acceptable when it is in line with the subject's preferred and usual lifestyle. If a subject is usually not sexually active but becomes active with their partner, they must comply with the contraceptive requirements detailed above.
- •Male subjects should not donate sperm for the duration of the study and for at least 30 days after last IMP administration.
排除标准
- •Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 60 to 90 mmHg, or pulse rate outside the range of 40 to 100 bpm at screening and pre-dose of first period
- •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, including not resolved post-vaccination reactions
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological 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, unless within the last 12 months)
- •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.
结局指标
主要结局
Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: up to 5 days
次要结局
- Area under the concentration-time curve of BI 685509 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 5 days)
研究者
研究点 (2)
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