NCT03844906CompletedPhase 1
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
Supernus Pharmaceuticals, Inc.1 site in 1 country40 target enrollmentStarted: December 27, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
Study Overview
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 pharmacokinetics in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
SAGE-718
Experimental
Intervention: SAGE-718 (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
Time Frame: From Day 1 through Day 11
Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo
Time Frame: From Day 1 through Day 11
Secondary Outcomes
- Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.(Between Baseline and Day 26)
Investigators
Study Sites (1)
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