An Open-label, Fixed-sequence, Non-randomised, Drug-drug Interaction Study to Evaluate the Effect of Pantoprazole (Proton Pump Inhibitor) on the Pharmacokinetics of CHF10196 in Healthy Male Participants.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- PK parameter: AUC0-∞
研究概览
简要总结
This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants. Participants receive CHF10196 alone and in combination with pantoprazole to assess potential drug-drug interaction (DDI) effects on systemic exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •BMI (body mass index) between 18.0 and 30.0 kg/m²
- •Weight between 45 and 100 kg
- •Non-smokers or ex-smokers (<5 pack-years)
- •Clinically healthy based on medical history and examination
- •Normal vital signs
- •Normal ECG
- •Willingness to comply with contraception requirements
排除标准
- •Recent participation in another clinical study
- •Significant medical conditions
- •Abnormal laboratory values
- •Positive HIV or hepatitis tests
- •Recent infection or COVID-19
- •Drug or alcohol abuse
- •Use of prohibited medications
- •Gastrointestinal surgery affecting absorption
- •Hypersensitivity to study drugs
结局指标
主要结局
PK parameter: AUC0-∞
时间窗: pre-dose up to 168 hours post-dose
comparing the ratio of adjusted geometric means for area under the concentration time curve from time 0 extrapolated to infinity (AUC0-∞) when CHF10196 administered alone and when administered with pantoprazole
PK parameter: AUC0-t
时间窗: pre-dose up to 168 hours post-dose
comparing the ratio of adjusted geometric means for area under the plasma concentration time curve from time 0 to last quantifiable concentration (AUC0-t) when CHF10196 administered alone and when administered with pantoprazole
PK parameter: Cmax
时间窗: pre-dose up to 168 hours post-dose
comparing the ratio of adjusted geometric means for maximum observed concentration when CHF10196 administered alone and when administered with pantoprazole
次要结局
- Safety and tolerability: Incidence of adverse events (AE)(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)
- Safety and tolerability: Change from baselines for vital signs: PR(Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2)
- Safety and tolerability: Change from baselines for vital signs - RR(Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2)
- Safety and tolerability: Change from baselines for vital signs - blood pressure(Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2)
- Additional pharmacokinetic parameters: t1/2(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)
- Safety and tolerability: Change from baselines for ECG(Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2)
- Safety and tolerability: Change from baseline for ECG (HR)(Day 1 to Day 7 for treatment period 1 and Day 8 to Day 19 for treatment period 2)
- Safety and tolerability: Change from baseline for laboratory abnormalities(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)
- Additional pharmacokinetic parameters: AUC0-24h(From Day 1 to Day 2 for treatment period 1; from Day 13 to Day 14 for treatment period 2)
- Additional pharmacokinetic parameters: CL/F(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)
- Additional pharmacokinetic parameters: Vd/F(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)
- Additional pharmacokinetic parameters: tmax(From baseline (Day -1) to Day 8 for treatment period 1; from Day 8 to Day 20 for treatment period 2)