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

Bipolar I Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04987658
• Other study ID #: ALKS 3831-A311
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2021
• Est. completion date: August 11, 2023

Study information

• Verified date: November 2023
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 11, 2023
• Est. primary completion date: August 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

Drug:
• OLZ/SAM
Olanzapine and Samidorphan taken once daily over a max period of 21 days

Locations

Country	Name	City	State
United States	Alkermes Clinical Investigative Site	Cincinnati	Ohio
United States	Alkermes Investigational Site	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration observed		Up to 3 weeks
Primary	Area under the plasma concentration-time curve over the 24-hour dosing interval		Up to 3 weeks
Primary	Time to reach maximum concentration		Up to 3 weeks
Primary	Incidence of Adverse Events		Up to 6 weeks