HealthyPhase 1NCT03284931
A Study to Assess the Pharmacodynamic Effects of SAGE-217 in Healthy Adults Using an Insomnia Model
A Phase 1 study testing SAGE-217 high dose and SAGE-217 low dose in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SAGE-217 high dose and SAGE-217 low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 18 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.
Read the 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.
- Conditions
- Healthy
- Being tested
- SAGE-217 high dose, Placebo, SAGE-217 low dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAGE-217 high doseDrug
high dose
PlaceboDrug
placebo
SAGE-217 low doseDrug
low dose
| Study group | Role | What they receive |
|---|---|---|
| SAGE-217 high dose | Experimental | SAGE-217 Receives: Drug: SAGE-217 high dose |
| SAGE-217 low dose | Experimental | SAGE-217 Receives: Drug: SAGE-217 low dose |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency, as determined by polysomnography (PSG)
Measured: 16 days
Secondary outcomes (5)
Safety and tolerability, as assessed by adverse events
Measured: 36 days
Safety and tolerability, as assessed by vital signs
Measured: 29 days
Safety and tolerability, as assessed by clinical laboratory data
Measured: 29 days
Safety and tolerability, as assessed by ECG
Measured: 29 days
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start14 Sep 2017
- Primary completion4 Dec 2017
- Study completion18 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284931
- Sponsor's protocol ID
- 217-EXM-101
- Status last verified
- Nov 2023
- First submitted
- 13 Sep 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03284931
- Acronym / sponsor ID
- 217-EXM-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAGE-217 high dose | Experimental | Drug: SAGE-217 high doseSAGE-217 |
| SAGE-217 low dose | Experimental | Drug: SAGE-217 low doseSAGE-217 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAGE-217 high dosehigh dose | Drug | SAGE-217 high dose |
| Placeboplacebo | Drug | Placebo |
| SAGE-217 low doselow dose | Drug | SAGE-217 low dose |
Primary outcome
Sleep efficiency, as determined by polysomnography (PSG)
Time frame: 16 days
5 secondary outcomes
Safety and tolerability, as assessed by adverse events
Time frame: 36 days
Safety and tolerability, as assessed by vital signs
Time frame: 29 days
Safety and tolerability, as assessed by clinical laboratory data
Time frame: 29 days
Safety and tolerability, as assessed by ECG
Time frame: 29 days
Safety and tolerability, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAGE-217 high dose and SAGE-217 low dose in people with Healthy, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency, as determined by polysomnography (PSG) (time frame: 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.