NCT03524066

Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)

Understanding the Lung Pharmacokinetics (PK) in Humans by Direct Sampling of Epithelial Lining Fluid (ELF) After Inhalation and Oral Administration of Model Drugs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fraunhofer-Institute of Toxicology and Experimental Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The aim of the present study is to increase the general understanding of lung PK of selected compounds by sampling epithelial lining fluid ELF and lung tissue.

Detailed description

This study will investigate drug levels of selected compounds at multiple sites in the lung and explore different innovative sampling methods to obtain information on lung PK. The aim of the study is not to generate safety or efficacy data of the selected licensed drugs. The choice of drugs is based on general considerations regarding therapy of airway diseases and the physical-chemical properties of the compounds. It is not driven by the compounds per se.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Inhalation	Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation
DRUG	Systemic	Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally
OTHER	Bronchoscopy	Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy

Timeline

• Start date: 2018-04-10
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-05-14
• Last updated: 2019-02-15

Locations

1 site across 1 country: Germany