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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

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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

Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE December 27, 2018
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2019)
Number of Participants with the Incidence of Adverse Events and Serious Adverse Events. [ Time Frame: Between Baseline and Day 26 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: SAGE-718
    SAGE-718 in combination with Ketamine
  • Drug: Placebo
    Placebo in combination with Ketamine
Study Arms  ICMJE
  • Experimental: SAGE-718
    Intervention: Drug: SAGE-718
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2019
Actual Primary Completion Date March 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03844906
Other Study ID Numbers  ICMJE 718-EXM-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sage Therapeutics
Study Sponsor  ICMJE Sage Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sage Therapeutics
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP