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Completed

NCT Number: NCT03284931

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

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

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sage Investigational Site

New York, 10019, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAGE-217 high dose

Drug

high dose

Placebo

Drug

placebo

SAGE-217 low dose

Drug

low dose

Primary outcomes

  1. Sleep efficiency, as determined by polysomnography (PSG)

    Time frame: 16 days

Secondary outcomes

  1. Safety and tolerability, as assessed by adverse events

    Time frame: 36 days

  2. Safety and tolerability, as assessed by vital signs

    Time frame: 29 days

  3. Safety and tolerability, as assessed by clinical laboratory data

    Time frame: 29 days

  4. Safety and tolerability, as assessed by ECG

    Time frame: 29 days

  5. Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: 29 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multiple Dose, 3-way Crossover, Exploratory Study to Assess the Pharmacodynamic Effects of SAGE-217 Capsules in Healthy Adults Using a 5-hour Phase Advance Model of Insomnia

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 15, 2017
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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