Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
accepted:
21
11
2021
pubmed:
29
12
2021
medline:
18
5
2022
entrez:
28
12
2021
Statut:
ppublish
Résumé
Selatogrel is a potent, reversible, and selective antagonist of the platelet P2Y This was a single-center, randomized, open-label, three-period, cross-over Phase I study in 24 healthy subjects. In each period, a single subcutaneous dose of 16 mg selatogrel was administered as (1) a Phase III liquid formulation by autoinjector (Treatment A), (2) a Phase III liquid formulation by prefilled syringe (Treatment B), or (3) a Phase I/II reconstituted lyophilizate-based formulation by syringe (Treatment C). PK parameters including area under the plasma concentration-time curve from zero to infinity (AUC Comparing Treatment A to Treatment C, the exposure (AUC PK and simulated PD effects of selatogrel were similar across treatments. NCT04557280.
Sections du résumé
BACKGROUND AND OBJECTIVES
Selatogrel is a potent, reversible, and selective antagonist of the platelet P2Y
METHODS
This was a single-center, randomized, open-label, three-period, cross-over Phase I study in 24 healthy subjects. In each period, a single subcutaneous dose of 16 mg selatogrel was administered as (1) a Phase III liquid formulation by autoinjector (Treatment A), (2) a Phase III liquid formulation by prefilled syringe (Treatment B), or (3) a Phase I/II reconstituted lyophilizate-based formulation by syringe (Treatment C). PK parameters including area under the plasma concentration-time curve from zero to infinity (AUC
RESULTS
Comparing Treatment A to Treatment C, the exposure (AUC
CONCLUSIONS
PK and simulated PD effects of selatogrel were similar across treatments.
CLINICAL TRIAL REGISTRATION
NCT04557280.
Identifiants
pubmed: 34961905
doi: 10.1007/s40262-021-01097-9
pii: 10.1007/s40262-021-01097-9
doi:
Substances chimiques
Organophosphonates
0
Pyrimidines
0
selatogrel
6DPK7O4PR7
Banques de données
ClinicalTrials.gov
['NCT04557280']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
687-695Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
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