Overview
A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
Status:
Completed
Completed
Trial end date:
2019-04-01
2019-04-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Sage TherapeuticsTreatments:
Ketamine
Criteria
Inclusion Criteria:1. Subject has a body weight ≥50 kg and body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 at
screening.
2. Subject is healthy with no history or evidence of clinically relevant medical
disorders as determined by the Investigator.
Exclusion Criteria:
1. Subject has any clinically significant abnormal value for hematology, clinical
chemistry, or urinalysis at screening or admission.
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 positive screening test for alcohol or drugs of abuse (including
marijuana) at screening or admission.