Zuranolone Pharmacokinetics (PK) and Safety Study Adolescent Participants With Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the pharmacokinetics and safety of Zuranolone in adolescents (ages 12 to 17 years) with MDD.

Official Title
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A Phase 1, Study to Evaluate the Pharmacokinetics and Safety of Zuranolone in Adolescents (12 to 17 Years of Age) With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Zuranolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant meets Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime DSM-5 (KSADS-PL DSM-5) criteria for MDD. Participant has a Children's Depression Rating Scale-Revised (CDRS-R) total score greater than or equal to 40 at screening and Day 1. Participant's parent/caregiver is able to attend all scheduled study visits, oversee administration of study drug and complete assessments per the protocol. Participant has a body weight greater than or equal to 20 kg and a body mass index greater than fifth percentile and less than ninety-fifth percentile for age at Screening. Participant is a post-pubertal (has experienced menarche) female (sex assigned at birth), 12 to 17 years of age, inclusive, at the time informed consent/assent is obtained. Exclusion Criteria: Participant has a history of psychosis, bipolar disorder, autism, seizures, or other restricted comorbid psychiatric or neurological conditions and has treatment-resistant depression. Participant has a known diagnosis of intellectual disability or is unable to communicate with the study investigator or research team. Participant has a history of suicidal behavior or is currently at risk of suicide in the opinion of the investigator. Participant has a recent history of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) alcohol or drug use disorder or has clinically significant alcohol or drug misuse as judged by the investigator. Note: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zuranolone<br>Participants will be enrolled to receive Zuranolone orally, during the daytime on Day 1 and in the evening on Days 2 to 14. The first 10 enrolled participants will receive 50 mg (participants with a body weight of 54 kg or greater) or 40 mg (participants with a body weight less than 54 kg) once daily. The remaining participants will receive 40 mg once daily with the opportunity to down titrate to 30 mg if 40 mg is not tolerated. | Drug: Zuranolone<br>* Administered as capsules<br>* Other names: SAGE-217, BIIB125;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentrations of Zuranolone | PK Parameters of Zuranolone will be assessed. | At multiple timepoints post dose on Days 1, 8 and 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE) |  | Up to 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, MDD, Depression, Pediatrics, Child, Adolescent, SAGE-217, Zuranolone