This study is a phase 1, double-blind, placebo-controlled, multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of SAGE-718 oral solution in healthy adults (Part A) with an open-label cohort of patients with Huntington's disease (Part B)
This posting addresses Part B
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
SAGE-718
Sage Investigational Site
Long Beach, California, United States
Sage Investigational Site
Marlton, New Jersey, United States
Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.
Time frame: 21 Days
Percentage of participants with change from baseline in vital signs.
Time frame: 21 Days
Change from baseline in electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Time frame: 21 Days
Percentage of participants with change from baseline in clinical laboratory parameters.
Time frame: 21 Days
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: 21 Days
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by area under the curve [AUC].
Time frame: 17 Days
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by maximum observed concentration [Cmax].
Time frame: 17 Days
PK profile of SAGE-718 following administration of multiple doses of SAGE-718 Oral Solution as assessed by time of occurrence of Cmax [tmax].
Time frame: 17 Days
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