A Study to Assess the Pharmacodynamic Effects of SAGE-217... | NCT03284931

Studies
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model

NCT03284931

Sponsor

Biogen

Status

Completed

Last Update Posted

Nov 29, 2023Actual

Enrollment

45Actual

Phase

Phase 1

Conditions

Healthy

Interventions

SAGE-217 high dose
Placebo
SAGE-217 low dose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 14, 2017Actual

Primary Completion Date

Dec 4, 2017Actual

Completion Date

Dec 18, 2017Actual

First Submitted Date

Sep 13, 2017

First Submission Date that Met QC Criteria

Sep 13, 2017

First Posted Date

Sep 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2023

Last Update Posted Date

Nov 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.

Detailed Description

Subjects are expected to complete Treatment Periods 1, 2 and 3, followed by an optional open-label administration of SAGE-217 for pharmacokinetic purposes (Treatment Period 4).

This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAGE-217 high dose	Experimental	SAGE-217	Drug: SAGE-217 high dose
SAGE-217 low dose	Experimental	SAGE-217	Drug: SAGE-217 low dose
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAGE-217 high dose	Drug	high dose	SAGE-217 high dose
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep efficiency, as determined by polysomnography (PSG)		16 days

Secondary Outcomes

Measure	Description	Time Frame
Safety and tolerability, as assessed by adverse events		36 days
Safety and tolerability, as assessed by vital signs		29 days
Safety and tolerability, as assessed by clinical laboratory data

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is willing and able to participate in the study, including all assessments, planned inpatient stays and all follow-up visits
Subject is a healthy, ambulatory volunteer
Subject meets sleep Qualification criteria

Exclusion Criteria:

Subject has a medical history of suicidal behavior, epilepsy, eating disorders, sleep disorders, or circadian rhythm disorders
Subject has worked a night shift or flown >1 time zone within 30 days prior to Screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sage Investigational Site		New York	New York	10019	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

https://vivli.org/

Intervention Browse Module

MeSH Terms

ID	Term
C000634505	zuranolone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided