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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23987
Enrollment
26
Registered
2020-09-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung disease

Interventions

Seven days nintedanib taken with 500 mg green tea extract (with > 60% ECGC)

Sponsors

Erasmus MC dept. of Medical Oncology and dept. of Pulmonology
Lead Sponsor

Eligibility

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

MeasureTime frame
Change in nintedanib bioavailability, expressed in area under the plasma curve (AUC).—

Secondary

MeasureTime frame
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.—

Contacts

Public ContactG.D. Marijn Veerman

Erasmus MC

g.veerman@erasmusmc.nl0641531792

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)