Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
- Conditions
- Short Bowel SyndromeAnticoagulation
- Interventions
- Registration Number
- NCT04344717
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Healthy volunteers Apixaban single dose Apixaban- and vitamin K antagonist naive healty volunteers Patients with a normal gastrointestinal tract on apixaban Apixaban steady-state Patients with a normal gastrointestinal tract taking apixaban 2.5 mg twice daily or 5 mg twice daily Anticoagulation naive short bowel syndrome on teduglutide Apixaban single dose Apixaban- and vitamin K antagonist naive patients with short bowel syndrome requiring long term parenteral support and initiated on teduglutide Short bowel syndrome on apixaban Apixaban steady-state Patients with short bowel syndrome requiring long term parenteral support and taking apixaban 2.5 mg twice daily or 5 mg twice daily Anticoagulation and teduglutide naive short bowel syndrome Apixaban single dose Apixaban-, vitamin K antagonist- and teduglutide naive patients with short bowel syndrome requiring long term parenteral support
- Primary Outcome Measures
Name Time Method Difference in Cmax of apixaban between SBS and patients with a normal gastrointestinal tract 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
- Secondary Outcome Measures
Name Time Method 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 To investigate differences in Tmax after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
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 To investigate the difference in absorption rate constant between patients with and without SBS requiring long-term PN
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 To investigate the difference in volume of distribution between patients with and without SBS requiring long-term PN
Difference in clearance of apixaban between SBS patients and patients with a normal gastrointestinal tract Through study completion, an average of 1.5 years To investigate the difference in clearance between patients with and without SBS requiring long-term PN
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 To investigate differences in estimated Cmin (12h after administration) after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
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 To investigate differences in AUC0-12 after two different single dose administrations (2,5 mg and 5 mg) of apixaban between patients with and without SBS requiring long-term PN
Difference in bioavailability of apixaban between SBS patients and patients with a normal gastrointestinal tract Through study completion, an average of 1.5 years To investigate the difference in bioavailability between patients with and without SBS requiring long-term PN
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 To investigate the difference in half-life between patients with and without SBS requiring long-term PN
Difference in absorption rate constant between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in absorption rate constant between SBS patients with and without teduglutide
Difference in bioavailability between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in bioavailability between SBS patients with and without teduglutide
Difference in volume of distribution between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in volume of distribution between SBS patients with and without teduglutide
To set up an optimized dosing scheme of apixaban for SBS patients Through study completion, an average of 1.5 years To set up an optimized dosing scheme of apixaban, using PK modeling, for SBS patients taking into account identified covariates (eg. sex, age, race...) and PK measurements from outcome 1-9.
Difference in Cmax between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in Cmax between SBS patients with and without teduglutide
Difference in Cmin between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in Cmin between SBS patients with and without teduglutide
Difference in Tmax between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in Tmax between SBS patients with and without teduglutide
Difference in AUC SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in Cmax, Cmin, Tmax, AUC, absorption rate constant, bioavailability, volume of distribution, clearance and half-life between SBS patients with and without teduglutide
Difference in half-life between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in half-life between SBS patients with and without teduglutide
Difference in AUC between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in Cmax, Cmin, Tmax, AUC, absorption rate constant, bioavailability, volume of distribution, clearance and half-life between SBS patients with and without teduglutide
Difference in clearance between SBS patients with and without teduglutide Through study completion, an average of 1.5 years To investigate the difference in clearance between SBS patients with and without teduglutide
Trial Locations
- Locations (1)
University Hospitals Leuven
🇧🇪Leuven, Belgium