SAGE-217, A Novel GABA
Administration, Oral
Adult
Allosteric Regulation
Depression, Postpartum
/ epidemiology
Depressive Disorder, Major
/ drug therapy
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
GABA-A Receptor Agonists
/ administration & dosage
Healthy Volunteers
Humans
Male
Middle Aged
Pharmacology, Clinical
/ methods
Placebos
/ administration & dosage
Pregnanes
/ administration & dosage
Pyrazoles
/ administration & dosage
Safety
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
pubmed:
25
7
2019
medline:
11
5
2021
entrez:
25
7
2019
Statut:
ppublish
Résumé
SAGE-217, a novel γ-aminobutyric acid A (GABA In the SAD study, subjects were randomized 6:2 to a single dose of SAGE-217 or placebo. Doses ranged from 0.25 to 66 mg across nine cohorts. In the MAD study, subjects were randomized 9:3 and received SAGE-217 (15, 30, or 35 mg) or placebo once daily for 7 days. In both studies, PK, maximum tolerated dose (MTD; against predetermined criteria), safety, and tolerability were assessed. A total of 108 healthy volunteers enrolled in the studies-72 subjects in the SAD study and 36 subjects in the MAD study. SAGE-217 was orally bioavailable, with a terminal-phase half-life of 16-23 h and a t SAGE-217 was generally well tolerated, and its PK profile was well characterized. Based on this profile, SAGE-217 has been advanced into multiple phase II clinical programs and pivotal studies of major depressive disorder and postpartum depression.
Sections du résumé
BACKGROUND
SAGE-217, a novel γ-aminobutyric acid A (GABA
METHODS
In the SAD study, subjects were randomized 6:2 to a single dose of SAGE-217 or placebo. Doses ranged from 0.25 to 66 mg across nine cohorts. In the MAD study, subjects were randomized 9:3 and received SAGE-217 (15, 30, or 35 mg) or placebo once daily for 7 days. In both studies, PK, maximum tolerated dose (MTD; against predetermined criteria), safety, and tolerability were assessed.
RESULTS
A total of 108 healthy volunteers enrolled in the studies-72 subjects in the SAD study and 36 subjects in the MAD study. SAGE-217 was orally bioavailable, with a terminal-phase half-life of 16-23 h and a t
CONCLUSIONS
SAGE-217 was generally well tolerated, and its PK profile was well characterized. Based on this profile, SAGE-217 has been advanced into multiple phase II clinical programs and pivotal studies of major depressive disorder and postpartum depression.
Identifiants
pubmed: 31338688
doi: 10.1007/s40262-019-00801-0
pii: 10.1007/s40262-019-00801-0
pmc: PMC6994455
doi:
Substances chimiques
GABA-A Receptor Agonists
0
Placebos
0
Pregnanes
0
Pyrazoles
0
zuranolone
7ZW49N180B
Types de publication
Clinical Trial, Phase I
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
111-120Références
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