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

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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.


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.
We found this trial at
2
sites
Berlin, New Jersey 08009
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Berlin, NJ
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Long Beach, California 90806
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Long Beach, CA
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