- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05049343
Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
January 20, 2022 updated by: Sage Therapeutics
A Phase 1, Double-Blind, Placebo-Controlled Crossover Study of SAGE-904 Using a Ketamine Challenge to Evaluate Electrophysiology, Safety, Tolerability, and Pharmacokinetics in Healthy Participants
The primary purpose of this study is to determine functional target engagement of SAGE-904 using electrophysiological paradigms before and after ketamine administration.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Sage Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participant is willing and able to provide 2 forms of identification; at least 1 must have a photo
- Participant has a body weight ≥50 kilograms (kg) and body mass index ≥18.0 and ≤30.0 kilograms per square meter (kg/m^2) at screening
- Participant is healthy with no history or evidence of clinically relevant medical disorders as determined by the investigator
- Participant has the ability to tolerate the electrode headset for the duration of the testing session
Exclusion Criteria:
- Participant has a history or presence of any psychiatric disease or condition including suicidal ideation or behavior, has answered YES to any question on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or admission, or is currently at risk of suicide in the opinion of the Investigator
- Participant has a history or presence of a neurologic disease or condition, including, but not limited to, epilepsy, closed head trauma with clinically significant (CS) sequelae, or a prior seizure
- Participant has a family history of epilepsy
- Participant has a history, presence, and/or current evidence of serologic positive results for Hepatitis B and C, human immunodeficiency virus (HIV) 1 or 2
- Participant 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 pharmacokinetic (PK) sample or affect the ability to receive the ketamine infusions
- Participant has had previous exposure to or is known to be allergic to ketamine or any of its excipients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAGE-904 then Placebo
SAGE-904 in combination with ketamine, followed by a washout period, followed by placebo in combination with ketamine.
|
SAGE-904 oral solution.
Placebo oral solution.
Ketamine intravenous (IV) infusion.
|
Placebo Comparator: Placebo then SAGE-904
Placebo in combination with ketamine, followed by a washout period, followed by SAGE-904 in combination with ketamine.
|
SAGE-904 oral solution.
Placebo oral solution.
Ketamine intravenous (IV) infusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Electrophysiological Parameter: Auditory Evoked Potential (AEP) in a Single-stimulus Paradigm Before and After Ketamine Infusion in Participants Receiving SAGE-904 Versus (vs) Participants Receiving Placebo
Time Frame: Pre-dose and post-dose on Days 1 and 11
|
AEP variables will include individual amplitudes of N100 and P200 responses and the derived peak-to-peak amplitude of these responses (N100-P200) in microvolts (µV).
|
Pre-dose and post-dose on Days 1 and 11
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Change in Electrophysiological Parameter: Mismatch Negativity (MMN) Before and After Ketamine Infusion in Participants Receiving SAGE-904 vs Participants Receiving Placebo
Time Frame: Pre-dose and post-dose on Days 1 and 11
|
MMN is a response to nonmatching sounds in a series of matching sounds.
Two tones of the same frequency and sound intensity, but differing in duration, will be sequentially presented to the participant through insert earphones.
MMN amplitude will be measured from the peak of a mid-latency negative voltage deflection in the difference waveform representing the response to deviant stimuli in µV.
|
Pre-dose and post-dose on Days 1 and 11
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Change in Electrophysiological Parameter: Auditory Steady-state Response (ASSR) Power Before and After Ketamine Infusion in Participants Receiving SAGE-904 vs Participants Receiving Placebo
Time Frame: Pre-dose and post-dose on Days 1 and 11
|
ASSR is used to assess the integrity of sensory pathways including cortical processing.
ASSR will be measured at midline central electrode (Cz) of electroencephalogram (EEG) to assess the response in hertz (Hz).
In ASSR, streams of "click" stimuli will be presented at a rate of 40 Hz while the participant will be instructed to fix their gaze on a white cross displayed on a computer monitor.
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Pre-dose and post-dose on Days 1 and 11
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Change in Electrophysiological Parameter: P300 in a Target Detection Paradigm as Assessed by Auditory Response Before and After Ketamine Infusion in Participants Receiving SAGE-904 vs Participants Receiving Placebo
Time Frame: Pre-dose and post-dose on Days 1 and 11
|
Improvement of the P300 auditory response time in milliseconds using P300 AEP in a target detection paradigm by an increase in amplitude and/or a decrease in latency will be analyzed.
In this paradigm, 2 tones of the same sound intensity, but differing in frequency, are sequentially presented to the participant through insert earphones.
The "standard" (low frequency) stimuli will be presented on the majority of trials, with a "target" (high frequency) stimuli presented periodically at random.
The participant is told to listen for the "target" stimuli and press a button on the handset as fast as they can.
The endpoint variables of P300 amplitude and latency in correlation with the button press reaction time will be used to assess the response time.
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Pre-dose and post-dose on Days 1 and 11
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 25
|
An adverse event (AE) is any untoward medical occurrence in a patients or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
A TEAE is defined as an AE with onset after the start of investigational product (IP), or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study.
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Up to Day 25
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2021
Primary Completion (Actual)
November 20, 2021
Study Completion (Actual)
December 3, 2021
Study Registration Dates
First Submitted
September 10, 2021
First Submitted That Met QC Criteria
September 10, 2021
First Posted (Actual)
September 20, 2021
Study Record Updates
Last Update Posted (Actual)
January 21, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 904-TRM-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data sharing will be consistent with the results submission policy of ClinicalTrials.gov.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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