Absolute Bioavailability of Osimertinib in Healthy Adults.
Acrylamides
/ administration & dosage
Administration, Intravenous
Administration, Oral
Adult
Aniline Compounds
/ administration & dosage
Biological Availability
Drug Administration Schedule
Female
Healthy Volunteers
Humans
Male
Mass Spectrometry
Middle Aged
Protein Kinase Inhibitors
/ administration & dosage
Young Adult
absolute bioavailability
microtracer
non-small cell lung cancer
osimertinib
pharmacokinetics
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
16
11
2017
accepted:
12
03
2018
pubmed:
24
4
2018
medline:
9
4
2020
entrez:
24
4
2018
Statut:
ppublish
Résumé
Osimertinib is a third-generation, central nervous system-active, epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) selective for EGFR-TKI sensitizing and T790M resistance mutations. This phase 1, open-label study (NCT02491944) investigated absolute bioavailability and pharmacokinetics (PK) of oral and intravenous (IV) osimertinib. Ten healthy subjects (21-61 years) received a single oral 80-mg dose concomitantly with a 100 μg (containing 1 μCi) IV microtracer dose of [
Substances chimiques
Acrylamides
0
Aniline Compounds
0
Protein Kinase Inhibitors
0
osimertinib
3C06JJ0Z2O
Banques de données
ClinicalTrials.gov
['NCT02491944']
Types de publication
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
198-207Informations de copyright
© 2018, The American College of Clinical Pharmacology.