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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SAGE-217 high dose; Drug: SAGE-217 low dose; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03284931

217-EXM-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

SAGE-217 high dose

Experimental group

Description:

SAGE-217

Treatment:

Drug: SAGE-217 high dose

SAGE-217 low dose

Experimental group

Description:

SAGE-217

Treatment:

Drug: SAGE-217 low dose

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo