Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT03524066
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2018-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
Sponsor:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: