Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Difference in Cmax of apixaban between SBS and patients with a normal gastrointestinal tract
研究概览
简要总结
Short bowel syndrome (SBS) is defined as a loss of function of the small intestine resulting in a malabsorptive disorder. In SBS, oral drug absorption may be altered due to extensive intestinal resection. It remains unclear to what extent apixaban exposure is impacted in SBS.Therefore this study tries to investigate the pharmacokinetics (PK) of apixaban in adult patients with SBS requiring long-term parenteral nutrition (PN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Anticoagulation and teduglutide naive short bowel syndrome
Apixaban-, vitamin K antagonist- and teduglutide naive patients with short bowel syndrome requiring long term parenteral support
干预措施: Apixaban single dose (Drug)
Healthy volunteers
Apixaban- and vitamin K antagonist naive healty volunteers
干预措施: Apixaban single dose (Drug)
Short bowel syndrome on apixaban
Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily
干预措施: Apixaban steady-state (Drug)
Patients with a normal gastrointestinal tract on apixaban
Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily
干预措施: Apixaban steady-state (Drug)
Anticoagulation naive short bowel syndrome on teduglutide
Apixaban- and vitamin K antagonist naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide
干预措施: Apixaban single dose (Drug)
结局指标
主要结局
Difference in Cmax of apixaban between SBS and patients with a normal gastrointestinal tract
时间窗: Through study completion, an average of 1.5 years
To investigate the difference in peak level (Cmax) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
次要结局
- Difference in time to reach Cmax (Tmax) of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in absorption rate constant of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in volume of distribution of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in clearance of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in estimated trough level (Cmin) of apixaban between SBS and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in exposure (AUC0-12h) of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in bioavailability of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in half-life of apixaban between SBS patients and patients with a normal gastrointestinal tract(Through study completion, an average of 1.5 years)
- Difference in absorption rate constant between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in bioavailability between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in volume of distribution between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- To set up an optimized dosing scheme of apixaban for SBS patients(Through study completion, an average of 1.5 years)
- Difference in Cmax between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in Cmin between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in Tmax between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in AUC SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in half-life between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in AUC between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)
- Difference in clearance between SBS patients with and without teduglutide(Through study completion, an average of 1.5 years)