Status:
COMPLETED
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
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 u...
Eligibility Criteria
Inclusion
- Subject is willing and able to provide 2 forms of identification; at least 1 must have a photo.
- Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
- Subject is healthy with no history or evidence of clinically relevant medical disorders as determined by the Investigator.
Exclusion
- 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
- 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.
- Subject has a family history of epilepsy.
- 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.
- Subject has claustrophobia or a history of claustrophobia.
- Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03770780
Start Date
November 12 2018
End Date
March 22 2019
Last Update
September 17 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sage Investigational Site
Long Beach, California, United States, 90806
2
Sage Investigational Site
Berlin, New Jersey, United States, 08009