Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

NCT ID: NCT04987658

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-22
• Study Completion Date: 2023-08-11

Brief Summary

To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following oral administration of multiple ascending doses of OLZ/SAM

Conditions

Bipolar I Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 Olanzapine/ 5 mg Samidorphan

Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 5mg (Range: 5-20mg Olanzapine/samidorphan 5mg)

Group Type: EXPERIMENTAL

OLZ/SAM

Intervention Type: DRUG

Olanzapine and Samidorphan taken once daily over a max period of 21 days

Group 2 Olanzapine/ 10mg Samidorphan

Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg)

Group Type: EXPERIMENTAL

OLZ/SAM

Intervention Type: DRUG

Olanzapine and Samidorphan taken once daily over a max period of 21 days

Interventions

OLZ/SAM

Olanzapine and Samidorphan taken once daily over a max period of 21 days

Intervention Type: DRUG

Other Intervention Names

ALKS 3831

Eligibility Criteria

Inclusion Criteria

• Subject's parent(s)/legal guardian(s) is considered reliable by the Investigator and has agreed to provide support to the subject to ensure compliance with study treatment, visits, and protocol procedures.
• Male and female subjects between 10 and 12 years of age, inclusive.
• Subject weighs ≥70 pounds.
• Subjects who are receiving antipsychotic treatment for their medical condition, with a diagnosis of bipolar I disorder.
• Subjects must be considered stable, per investigator judgement.
• Subject is willing to abide by the contraception requirements for the duration of the study.

Exclusion Criteria

• Subject has a comorbid neuropsychiatric disorder that could interfere with participation in the study.
• Subject poses a current suicide risk as assessed by the Investigator or as confirmed by the baseline Columbia-Suicide Severity Rating Scale by a response of "Yes" to question numbers 4 or 5 with ideation or suicidal behavior occurring in the past 12 months (assessed at Screening and at Visit 2, Day 1).
• Subject has a diagnosis of diabetes or presents with pre-diabetes lab results (hemoglobin A1c ≥6%).
• Subject has a history of use of clozapine or use of long-acting injectable antipsychotic medication within 3 months prior to Screening.
• Subject has a DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5) diagnosis of moderate to severe alcohol disorder, or moderate to severe substance use disorder, within the 3 months prior to Screening.
• Subject has taken opioid agonists within the 14 days prior to Screening, or has taken long-acting opioid agonist within the 30 days prior to Screening, or has anticipated a need to take opioid medication during the study period (eg, planned surgery, including oral surgery), or has taken opioid antagonists including naltrexone (any formulation) and naloxone within 60 days prior to Screening.
• Subject is unable to swallow oral medications, as assessed by the Investigator.
• Subject has a positive urine drug screen for opioids (assessed at Screening and at Visit 2, Day 1).
• Subject has a positive cotinine test (assessed at Screening and at Visit 2, Day 1).
• Subject has an intellectual disability, as assessed by the Investigator.
• Subject has a history of intolerance or hypersensitivity to olanzapine or opioid antagonists, or any component of the study drug.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alkermes, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David McDonnell, MD

Role: STUDY_DIRECTOR

Alkermes, Inc.

Locations

Alkermes Investigational Site

Decatur, Georgia, United States

Alkermes Clinical Investigative Site

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

ALKS 3831-A311

Identifier Type: -

Identifier Source: org_study_id