Trials / Unknown
UnknownNCT04344717
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apixaban single dose | A single dose of apixaban 2.5 mg and 5 mg (wash out period of at least 7 days) will be administered and PK characteristics will be measured |
| DRUG | Apixaban steady-state | Steady-state apixaban PK characteristics will be measured in patients already treated with apixaban |
Timeline
- Start date
- 2020-12-20
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2020-04-14
- Last updated
- 2024-02-23
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04344717. Inclusion in this directory is not an endorsement.