A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3009947 Administered Orally to Healthy Male Trial Participants, and a Randomised, Open-label, Single-dose, Three-way Cross-over Relative Bioavailability Comparison of Two Different Formulations for Oral Administration of BI 3009947 and the Effect of Food on One of These Formulations in Healthy Male Trial Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
Single-rising dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 3009947 in healthy participants following oral administration of single rising doses.
Bioavailability (BA) part:
The main objective of the BA part is to investigate the relative bioavailability of two different BI 3009947 formulations (Formulation A and B) and to assess the influence of food on the relative bioavailability of Formulation A or B.
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
盲法说明
SRD part: participants masked, single blind BA part: no masking, open label
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 trial participant 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 29.9 kg/m^2 (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
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 50 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- •Further exclusion criteria apply.
研究组 & 干预措施
SRD part: BI 3009947 Dose group 1
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 2
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 3
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 4
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 5
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 6
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 7
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: Placebo
干预措施: Placebo (Drug)
BA part: Treatment sequence R-T1-T2
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation A) (Drug)
BA part: Treatment sequence R-T1-T2
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation B) (Drug)
BA part: Treatment sequence T1-R-T2
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation A) (Drug)
BA part: Treatment sequence T1-R-T2
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation B) (Drug)
BA part: Treatment sequence T2-R-T1
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation A) (Drug)
BA part: Treatment sequence T2-R-T1
Reference treatment R and test treatments T1 and T2.
干预措施: BI 3009947 (Formulation B) (Drug)
SRD part: BI 3009947 Dose group 3fed
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 4fed
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 5fed
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 6fed
干预措施: BI 3009947 (Formulation A) (Drug)
SRD part: BI 3009947 Dose group 7fed
干预措施: BI 3009947 (Formulation A) (Drug)
结局指标
主要结局
SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to Day 14
This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
BA part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)
时间窗: up to Day 3
BA part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)
时间窗: up to Day 3
BA part: Cmax (maximum measured concentration of BI 3009947 in plasma)
时间窗: up to Day 3
BA part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)
时间窗: up to Day 3
次要结局
- SRD part: AUC0-24 (area under the concentration-time curve of BI 3009947 in plasma over the dosing interval 0 to 24 hours)(up to Day 3)
- SRD part: AUC0-24 (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the dosing interval 0 to 24 hours)(up to Day 3)
- SRD part: Cmax (maximum measured concentration of BI 3009947 in plasma)(up to Day 3)
- SRD part: Cmax (maximum measured concentration of the metabolite BI 3037996 in plasma)(up to Day 3)
- BA part: AUC0-∞ (area under the concentration-time curve of BI 3009947 in plasma over the time interval from 0 extrapolated to infinity)(up to Day 3)
- BA part: AUC0-∞ (area under the concentration-time curve of the metabolite BI 3037996 in plasma over the time interval from 0 extrapolated to infinity)(up to Day 3)