Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 1820237 Alone (Trial Parts 1+2) or Together With a Low Dose of Liraglutide (Trial Part 3) in Otherwise Healthy Male Subjects With Overweight/Obesity (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Percentage of subjects with drug-related adverse events
研究概览
简要总结
The main objective of this trial is to investigate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1820237 alone or together with a single low dose of liraglutide in male subjects with overweight/obesity (otherwise healthy) following subcutaneous administration of single rising doses.
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)
盲法说明
Within the central electrocardiogram (ECG) lab, the staff involved with interval measurements will be blinded with respect to the treatment and also with regard to the recording date and time as well as planned time points of the ECGs. The interval measurements for a given subject will be performed in a random and blinded sequence by a single technician.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects with overweight/obesity (otherwise healthy) 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 50 years (inclusive)
- •Body mass index (BMI) of 25.0 to 34.9 kg/m2 (inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator
- •Body weight greater than or equal to 70 kg
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
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 millimeter of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
- •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 medications 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
BI 1820237 + liraglutide
Part 3 of the trial.
干预措施: Saxenda® (Drug)
BI 1820237 + liraglutide
Part 3 of the trial.
干预措施: Paracetamol-ratiopharm® (Drug)
Placebo + liraglutide
Part 3 of the trial.
干预措施: Saxenda® (Drug)
Placebo + liraglutide
Part 3 of the trial.
干预措施: Placebo (Drug)
Placebo + liraglutide
Part 3 of the trial.
干预措施: Paracetamol-ratiopharm® (Drug)
BI 1820237
Part 1 and part 2 of the trial.
干预措施: BI 1820237 (Drug)
BI 1820237
Part 1 and part 2 of the trial.
干预措施: Paracetamol-ratiopharm® (Drug)
Placebo
Part 1 and part 2 of the trial.
干预措施: Placebo (Drug)
Placebo
Part 1 and part 2 of the trial.
干预措施: Paracetamol-ratiopharm® (Drug)
BI 1820237 + liraglutide
Part 3 of the trial.
干预措施: BI 1820237 (Drug)
结局指标
主要结局
Percentage of subjects with drug-related adverse events
时间窗: up to 48 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 38 days)
- Maximum measured concentration of the analyte in plasma (Cmax)(up to 38 days)