A Study to Assess the Electrophysiology, Safety, Tolerability, and Pharmacokinetics of SAGE-718 Using a Ketamine Challenge in Healthy Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/13/2019
Start Date:September 24, 2018
End Date:January 2, 2019

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A Phase 1, Double-blind, Placebo-controlled Crossover Study of SAGE-718 Using a Ketamine Challenge, to Evaluate the Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Subjects

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 pharmacokinetics in healthy subjects


Inclusion Criteria:

1. Subject has a body weight ≥50 kg and body mass index ≥18.0 and ≤30.0 kg/m2 at
screening.

2. 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).

3. Subject is healthy with no history or evidence of clinically relevant medical
disorders as determined by the Investigator.

Exclusion Criteria:

1. 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.

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 family history of epilepsy.

4. 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.

5. Subject has had previous exposure to or is known to be allergic to ketamine or any of
its excipients.
We found this trial at
2
sites
Long Beach, California 90806
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Long Beach, CA
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Berlin, New Jersey 08009
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Berlin, NJ
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