Interstitial lung disease lung fibrosis
Conditions
Interventions
Nintedanib will be used as standard care of treatment and is given in a dosage
of 100-150 mg twice daily. Dose modifications are not allowed during the whole
study period. Nintedanib will be adminis
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in nintedanib systemic bioavailability; area under the curve (AUC). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in other pharmacokinetic parameters i.e. maximal concentration (Cmax) and time to reach Cmax (Tmax). - Difference in occurrence of (patient reported) toxicity; safety of the combination of nintedanib and green tea capsules. | — |
Countries
Netherlands
Outcome results
None listed