Development of a sensitive LC-MS/MS assay to support human microdose study for an oral agonist of the GLP-1 receptor.
Bioanalysis
; 16(11): 545-555, 2024 Jun 02.
Article
em En
| MEDLINE
| ID: mdl-39088035
ABSTRACT
Aim:
The purpose of this work was to determine the feasibility of supporting a clinical microdose study for PF-06882961 (danuglipron), an oral small molecule agonist of the GLP-1 receptor, by LC-MS/MS.Methodology:
Statistical instrument parameter optimization using response surface methodology was employed to develop a LC-MS/MS method for the analyte, PF-06882961.Results:
An LC-MS/MS method was developed and validated to support a proof of concept microdose pharmacokinetics preclinical study in monkeys, administered PF-06882961 (0.005 mg total, average dose = 0.0007 mg/kg) via intravenous bolus injection.Conclusion:
The present study demonstrated the feasibility of analyzing human microdose plasma samples for PF-06882961 by LC-MS/MS, instead of accelerator mass spectrometry, thereby reducing cost and eliminating synthesis and exposure to 14C labeled material.
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Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Espectrometria de Massas em Tandem
/
Receptor do Peptídeo Semelhante ao Glucagon 1
Limite:
Animals
/
Humans
Idioma:
En
Revista:
Bioanal. (Online)
/
Bioanalysis
/
Bioanalysis (Online)
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos
País de publicação:
Reino Unido