Absolute bioavailability trial of oral imatinib (Glivec®) using a stable isotope labeled intravenous imatinib-d8 microdose
- Conditions
- Cancer, gastrointestinal stromal tumor, imatinib, absolute bioavailability
- Registration Number
- NL-OMON21434
- Lead Sponsor
- Antoni van Leeuwenhoek
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
1.Locally advanced or metastatic cancer;
2.On imatinib treatment at a stable dose of 400 mg once daily in the morning for at least 7 days (steady state plasma concentration)
Exclusion Criteria
Any treatment with investigational drugs within 30 days or 5 half-lives prior to receiving the investigational treatment;
2. Any treatment with inhibitors of CYP3A4 (e.g. boceprevir, claritromycine, erytromycine, indinavir, itraconazol, ketoconazol, ritonavir and voriconazol), inhibitors of Pgp (e.g. ciclosporine, kinidine and verapamil), inhibitors of BCRP (e.g. lapatinib), inductors of CYP3A4, Pgp or BCRP;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To ascertain whether the absolute bioavailability of oral imatinib (Glivec®) at steady state can be calculated using LC-MS/MS after concomitant administration of a single 100 µg microdose of stable isotope labeled imatinib (imatinib-d8).
- Secondary Outcome Measures
Name Time Method