CompletedPhase 1ketamine
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
Sponsored by Supernus Pharmaceuticals, Inc.
NCT ID
NCT03844906
Target Enrollment
40 participants
Start Date
2018-12-27
Est. Completion
2019-04-01
About This Study
This study is a Phase 1, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.
Conditions Studied
Interventions
- •SAGE-718
- •Placebo
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:Yes
View full eligibility criteria
Inclusion Criteria: 1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at screening. 2. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator. Exclusion Criteria: 1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission. 2. Subject has a history or presence of a neurologic disease or condition, including but not limited to epilepsy, closed head trauma with clinically significant sequelae, or a prior seizure. 3. Subject has a positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
Study Locations (2)
Sage Investigational Site
Long Beach, California, United States
Sage Investigational Site
Berlin, New Jersey, United States