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 |
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
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.
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