CompletedPhase 1ketamine
A Study to Assess the Electrophysiology, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response Using Magnetic Resonance Imaging of SAGE-718 Using a Ketamine Challenge in Healthy Subjects
Sponsored by Supernus Pharmaceuticals, Inc.
NCT ID
NCT03770780
Target Enrollment
19 participants
Start Date
2018-11-12
Est. Completion
2019-03-22
About This Study
This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic response using magnetic resonance imaging 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 is willing and able to provide 2 forms of identification; at least 1 must have a photo. 2. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening. 3. Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator. Exclusion Criteria: 1. Subject has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the C-SSRS at screening or admission, or is currently at risk of suicide in the opinion of the Investigator 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 family history of epilepsy. 4. Subject has evidence of any metal in the body that may be contraindicated for receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical implants, previous accident resulting in metal or shrapnel lodged internally, tattoos inked with metallic dyes, or a history of metal work without using protective eyewear. 5. Subject has claustrophobia or a history of claustrophobia. 6. Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
Study Locations (2)
Sage Investigational Site
Long Beach, California, United States
Sage Investigational Site
Berlin, New Jersey, United States