Status:
COMPLETED
A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics 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 single, oral dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety, tolerability, and phar...
Eligibility Criteria
Inclusion
- Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at screening.
- If female, subject is post-menopausal (at least 12 months of spontaneous amenorrhea with confirmatory follicle stimulating hormone \>40 mIU/mL), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, and/or hysterectomy).
- 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 obstructed venous access and/or has skin disease, rash, acne, or abrasion at venous access site that may affect the ability to obtain a PK sample or affect the ability to receive the ketamine infusions.
- Subject has had previous exposure to or is known to be allergic to ketamine or any of its excipients.
Key Trial Info
Start Date :
September 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03771586
Start Date
September 24 2018
End Date
January 2 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