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



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/20/2019
Start Date:November 12, 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 CROSSOVER STUDY OF SAGE-718 USING A KETAMINE CHALLENGE, TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMIC RESPONSE USING MAGNETIC RESONANCE IMAGING IN HEALTHY SUBJECTS

This study is a phase 1, double-blind, placebo-controlled crossover study of SAGE-718 using a
ketamine challenge, to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamic response using magnetic resonance imaging in healthy subjects


Inclusion Criteria:

1. Subject is willing and able to provide 2 forms of identification; at least 1 must have
a photo.

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

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 evidence of any metal in the body that may be contraindicated for
receiving an MRI. This includes, but is not limited to: cardiac pacemaker, surgical
implants, previous accident resulting in metal or shrapnel lodged internally, tattoos
inked with metallic dyes, or a history of metal work without using protective eyewear.

5. Subject has claustrophobia or a history of claustrophobia.

6. Subject is unable or unwilling to remove piercings and/or jewelry that contain metal.
We found this trial at
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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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