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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844906
• Other study ID #: 718-EXM-103
• Status: Completed
• Phase: Phase 1
• Start date: December 27, 2018
• Est. completion date: April 1, 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, randomized, double-blind, placebo-controlled study of multiple doses of SAGE-718 using ketamine challenge to evaluate the electrophysiology, safety, tolerability, and pharmacokinetics in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2019
• Est. primary completion date: March 18, 2019
• 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 (BMI) =18.0 and =30.0 kg/m2 at screening.

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

Exclusion Criteria:

1. Subject has any clinically significant abnormal value for hematology, clinical chemistry, or urinalysis at screening or admission.

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 positive screening test for alcohol or drugs of abuse (including marijuana) at screening or admission.

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	Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo		From Day 1 through Day 11
Primary	Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo		From Day 1 through Day 11
Secondary	Number of Participants with the Incidence of Adverse Events and Serious Adverse Events.		Between Baseline and Day 26