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

• ClinicalTrials.gov Identifier: NCT03844906
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: February 4, 2022
• Sponsor: Sage Therapeutics
• Information provided by (Responsible Party): Sage Therapeutics

Tracking Information

• First Submitted Date: December 19, 2018
• First Posted Date: February 19, 2019
• Last Update Posted Date: February 4, 2022
• Actual Study Start Date: December 27, 2018
• Actual Primary Completion Date: March 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Assess Electrophysiology, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of SAGE-718 Using Ketamine Challenge in Healthy Subjects
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Healthy Volunteer

Intervention

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

Study Arms

• Experimental: SAGE-718
  Intervention: Drug: SAGE-718
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2019): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 1, 2019
• Actual Primary Completion Date: March 18, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03844906
• Other Study ID Numbers: 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

• Plan to Share IPD: No
• Plan Description: Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.

• Current Responsible Party: Sage Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Sage Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sage Therapeutics
• Verification Date: January 2022