MedTrace Logo

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

NCT04987658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-11-22

No results posted yet for this study

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

Interventions

DRUG

OLZ/SAM

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

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Principal Investigators

  • David McDonnell, MD · Alkermes, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2023-08-11
Completion
2023-08-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04987658 on ClinicalTrials.gov