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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771586
• Other study ID #: 718-EXM-101
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2018
• Est. completion date: January 2, 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 single, oral dose of SAGE-718 using a ketamine challenge, to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2, 2019
• Est. primary completion date: December 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

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 the electrophysiological parameters, auditory evoked potentials, between pre- and post-ketamine infusion in subjects receiving SAGE-718 vs the change in parameters between pre- and post-ketamine infusion in subjects receiving placebo		Between Day 1 and Day 11
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by the 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 changes from baseline in 12-lead electrocardiograms (ECGs) including PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities	Observed values and change from baseline in ECGs in patients post study drug administration	Between Baseline and Day 12
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in electroencephalograms (EEGs) including Delta, Theta, Alpha, Beta.	Observed values and change from baseline in EEGs in patients post study drug administration	Between Baseline and Day 12
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS).		Between Baseline and 27 days
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Brief Psychiatric Rating Scale (BPRS).		Between Day 1 and Day 11
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Clinician Administered Dissociative State Scale (CADSS).		Between Day 1 and Day 11
Secondary	Safety and tolerability of SAGE-718-alone and in combination with ketamine, as assessed by changes from baseline in Observer's Assessment of Alertness and Sedation (OAAS).		Between Day 1 and Day 11

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