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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770780
• Other study ID #: 718-EXM-102
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2018
• Est. completion date: March 22, 2019

Study information

• Verified date: January 2022
• Source: Sage Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 22, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• SAGE-718
SAGE-718 in combination with Ketamine
• Placebo
Placebo in combination with Ketamine

Locations

Country	Name	City	State
United States	Sage Investigational Site	Berlin	New Jersey
United States	Sage Investigational Site	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Sage Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glutamate and glutamine (GLX) in the anterior cingulate cortex (ACC), hippocampus, and pons as measured with magnetic resonance spectroscopy (MRS)		Between Day 1 and Day 11
Secondary	Change in glutamate in the ACC, hippocampus, and pons, as measured with MRS		Between Day 1 and Day 11
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by incidence of adverse events (AEs)/serious AEs (SAEs)		Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electroencephalograms (EEGs)	Observed values and change from baseline in EEGs in patients post study drug administration	Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by electrocardiograms (ECGs)	Observed values and change from baseline in ECGs in patients post study drug administration	Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)		Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Brief Psychiatric Rating Scale (BPRS)		Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Clinician Administered Dissociative State Scale (CADSS)		Between Baseline and Day 27
Secondary	Safety and tolerability of SAGE-718 alone and in combination with ketamine, as assessed by Observer's Assessment of Alertness and Sedation (OAAS)		Between Baseline and Day 27