Influence of Flavonoids on the Absorption of Nintedanib: a Randomized, Cross-Over Pharmacokinetic Study (the INFLATE study)

• Conditions: Interstitial lung disease; lung fibrosis; 10024967

• Registration Number: NL-OMON49544
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

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
<p>Change in nintedanib systemic bioavailability; area under the curve (AUC). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change in other pharmacokinetic parameters i.e. maximal concentration (Cmax)<br /><br>and time to reach Cmax (Tmax).<br /><br>- Difference in occurrence of (patient reported) toxicity; safety of the<br /><br>combination of nintedanib and green tea capsules.</p><br>