An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of Dabigatran : AUC0-t
研究概览
简要总结
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.
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
- •Healthy male participants aged 18 to 55 years
- •Body mass index between 18.0 and 30.0 kg/m²
- •Non-smokers or ex-smokers (<5 pack-years)
- •Clinically healthy based on medical history and examination
- •Vital signs and ECG within normal limits
- •Willing and able to comply with study procedures
排除标准
- •Use of prohibited concomitant medications
- •Participation in another clinical study within 3 months
- •Clinically relevant medical conditions
- •Abnormal laboratory values
- •Positive HIV, hepatitis B, or hepatitis C
- •History of bleeding disorders
- •Drug or alcohol abuse
- •Use of nicotine-containing products within defined period
- •Recent COVID-19 infection
结局指标
主要结局
Pharmacokinetics of Dabigatran : AUC0-t
时间窗: Up to 72 hours after dosing
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided Confidential Intervals(CI), will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-t)
Pharmacokinetics of Dabigatran: AUC0-∞
时间窗: Up to 72 hours after dosing
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) area under the plasma concentration-time curve, from time 0 to the last measurable concentration (AUC0-∞)
Pharmacokinetics of Dabigatran: Cmax
时间窗: Up to 72 hours after dosing
comparing the ratios of adjusted geometric means between test 1 (dabigatran \[free and total\] with CHF10196) and reference 1 (dabigatran \[free and total\] alone), with 90% two-sided CIs, will be calculated for plasma dabigatran (free and total) maximum observed maximum observed concentration (Cmax)
Pharmacokinetics of Rosuvastatin :AUC0-t
时间窗: Up to 96 hours after dosing
The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin AUC0-t
Pharmacokinetics of Rosuvastatin : AUC0-∞
时间窗: Up to 96 hours after dosing
The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin (AUC0-∞)
Pharmacokinetics of Rosuvastatin: Cmax
时间窗: Up to 96 hours after dosing
The ratios of adjusted geometric means between test 2 (rosuvastatin with CHF10196) and reference 2 (rosuvastatin alone), with 90% two sided CIs, will be calculated for plasma rosuvastatin Cmax
次要结局
- Safety and Tolerability : Incidence of adverse events (AE)(From Baseline Day -1 until Day 8 of TP1 and from Day 8 to Day 20 of TP2)
- Safety and Tolerability : change from baseline for laboratory abnormalities(From Baseline Day -1 until Day 8 for TP1, and from Day 8 to Day 20 of TP 2)
- Safety and Tolerability: changes from baseline for vital signs - pulse rate(From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2)
- Additional Pharmacokinetic Parameters : CL/F of dabigatran(From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2)
- Safety and Tolerability: changes from baseline for vital signs - respiratory rate(From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2)
- Safety and Tolerability: changes from baseline for vital signs - blood pressure(From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2)
- Safety and Tolerability : change from baseline for ECG intervals(From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2)
- Safety and Tolerability : change from baseline for ECG HR(From Day 1 to Day 8 for TP1 and from Day 8 to Day 20 for TP2)
- Additional Pharmacokinetic Parameters: CL/F of resuvastatin(From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2)
- Additional Pharmacokinetic Parameters: Vd/F of dabigatran(From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2)
- Additional Pharmacokinetic Parameters: Vd/F of rosuvastatin(From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 forTP2)
- Additional Pharmacokinetic Parameters: tmax of dabigatran(From Day 1 to Day 4 for TP1 and from Day 13 to Day 16 for TP2)
- Additional Pharmacokinetic Parameters: tmax of rosuvastatin(From Day 4 to Day 8 for TP1 and from Day 16 to Day 20 for TP2)