Status:
COMPLETED
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using 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, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmaco...
Eligibility Criteria
Inclusion
- Subject has a body weight ≥50 kg and body mass index (BMI) ≥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 any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.
- 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 positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.
Key Trial Info
Start Date :
December 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03844906
Start Date
December 27 2018
End Date
April 1 2019
Last Update
September 17 2025
Active Locations (2)
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1
Sage Investigational Site
Long Beach, California, United States, 90806
2
Sage Investigational Site
Berlin, New Jersey, United States, 08009