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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844906
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: SAGE-718 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : December 27, 2018
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: SAGE-718 Drug: SAGE-718
SAGE-718 in combination with Ketamine

Placebo Comparator: Placebo Drug: Placebo
Placebo in combination with Ketamine




Primary Outcome Measures :
  1. Number of Participants With Changes in Electrophysiological Parameters Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo [ Time Frame: From Day 1 through Day 11 ]
  2. Number of Participants With Changes in Auditory-Evoked Potentials Pre- and Post-ketamine Infusion in Participants Receiving SAGE-718 vs Placebo [ Time Frame: From Day 1 through Day 11 ]

Secondary Outcome Measures :
  1. Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [ Time Frame: Between Baseline and Day 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844906


Locations
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United States, California
Sage Investigational Site
Long Beach, California, United States, 90806
United States, New Jersey
Sage Investigational Site
Berlin, New Jersey, United States, 08009
Sponsors and Collaborators
Sage Therapeutics
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT03844906    
Other Study ID Numbers: 718-EXM-103
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No