A phase 1 study to assess potential interaction between ASP8062 and alcohol in healthy adult subjects.
GABAB-receptor positive allosteric modulator
alcohol interaction
pharmacodynamics
pharmacokinetics
safety/tolerability
Journal
Journal of psychopharmacology (Oxford, England)
ISSN: 1461-7285
Titre abrégé: J Psychopharmacol
Pays: United States
ID NLM: 8907828
Informations de publication
Date de publication:
06 2022
06 2022
Historique:
pubmed:
8
1
2022
medline:
3
6
2022
entrez:
7
1
2022
Statut:
ppublish
Résumé
ASP8062 is a novel orally active GABA This study assessed the potential pharmacokinetic/pharmacodynamic interaction between ASP8062 and alcohol under single-dose conditions in healthy adults. A double-blind, placebo-controlled, crossover phase 1 study was conducted in which 20 subjects were randomly assigned to four treatment sequences (ASP8062 + alcohol; ASP8062 + placebo alcohol; placebo + alcohol; placebo + placebo alcohol) each consisting of four treatment periods, separated by washout periods of at least 14 days. An analysis of variance was used to assess pharmacokinetic interaction and a mixed-effects analysis of covariance was used to assess pharmacodynamic interaction. After administration of alcohol, a mild to minimal increase in plasma exposure (AUC The data support further clinical studies investigating ASP8062 in patients with AUD.
Sections du résumé
BACKGROUND
ASP8062 is a novel orally active GABA
AIMS
This study assessed the potential pharmacokinetic/pharmacodynamic interaction between ASP8062 and alcohol under single-dose conditions in healthy adults.
METHODS
A double-blind, placebo-controlled, crossover phase 1 study was conducted in which 20 subjects were randomly assigned to four treatment sequences (ASP8062 + alcohol; ASP8062 + placebo alcohol; placebo + alcohol; placebo + placebo alcohol) each consisting of four treatment periods, separated by washout periods of at least 14 days. An analysis of variance was used to assess pharmacokinetic interaction and a mixed-effects analysis of covariance was used to assess pharmacodynamic interaction.
RESULTS/OUTCOMES
After administration of alcohol, a mild to minimal increase in plasma exposure (AUC
CONCLUSION/INTERPRETATION
The data support further clinical studies investigating ASP8062 in patients with AUD.
Identifiants
pubmed: 34994232
doi: 10.1177/02698811211058967
doi:
Substances chimiques
ASP8062
0
Morpholines
0
Pyrimidines
0
Ethanol
3K9958V90M
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