Influence of Flavonoids on the Absorption of Nintedanib: a Randomized, Cross-Over Pharmacokinetic Study
- Conditions
- Interstitial Lung disease
- Registration Number
- NL-OMON23987
- Lead Sponsor
- Erasmus MC dept. of Medical Oncology and dept. of Pulmonology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 26
Inclusion Criteria
Age =18 years;
- Able to understand the written information and able to give informed consent;
- Planned treatment with nintedanib for any fibrotic ILD according to standard of care.
Exclusion Criteria
- unable to draw blood for study purposes
- usage of other strong P-gP or CYP3A4 interacting compounds
- patients with known impaired drug absorption (e.g. gastrectomy and achlorhydria)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in nintedanib bioavailability, expressed in area under the plasma curve (AUC).
- Secondary Outcome Measures
Name Time Method Change in other pharmacokinetic parameters i.e. maximal concentration (Cmax) and time to reach Cmax (Tmax) and a difference in occurrence of (patient reported) toxicity.