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

A Phase 1, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OLZ/SAM in Pediatric Subjects (10-12 Years Old) With Bipolar I Disorder

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

Study Overview

• Status: Completed
• Conditions: Bipolar I Disorder
• Intervention / Treatment: Drug: OLZ/SAM

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30030
      • Alkermes Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Alkermes Clinical Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: OLZ/SAM; Olanzapine and Samidorphan taken once daily over a max period of 21 days; Other Names: ALKS 3831
Experimental: Group 2 Olanzapine/ 10mg Samidorphan; Olanzapine will be gradually increased to a target dose of 10mg/samidorphan 10mg (Range: 5-20mg Olanzapine/samidorphan 10mg)	Drug: OLZ/SAM; Olanzapine and Samidorphan taken once daily over a max period of 21 days; Other Names: ALKS 3831

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum plasma concentration observed	Up to 3 weeks
Area under the plasma concentration-time curve over the 24-hour dosing interval	Up to 3 weeks
Time to reach maximum concentration	Up to 3 weeks
Incidence of Adverse Events	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: David McDonnell, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2021
• Primary Completion (Actual): August 11, 2023
• Study Completion (Actual): August 11, 2023

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Bipolar I Disorder; Samidorphan; Olanzapine; ALKS 3831; LYBALVI; OLZ/SAM; Pediatric pharmacokentics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: ALKS 3831-A311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No