A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/21/2019 |
| Start Date: | December 27, 2018 |
| End Date: | March 2019 |
| Contact: | Irena Webster |
| Email: | irena.webster@sagerx.com |
| Phone: | 617-949-4264 |
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
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.
of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability,
and pharmacokinetics in healthy subjects.
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.
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