An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

Schizophrenia Clinical Trial

Official title:

A 21-Week, Multicenter, Open-Label, Multiple-Dose Trial to Assess the Comparative Bioavailability of Olanzapine Prolonged-Release Suspension for Subcutaneous Administration (TV-44749) to Oral Olanzapine (European Reference) in Participants With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315283
• Other study ID #: TV44749-BA-10196
• Secondary ID: 2023-505664-11-0
• Status: Recruiting
• Phase: Phase 1
• Start date: March 20, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: April 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: Teva U.S. Medical Information
• Phone: 1-888-483-8279
• Email: USMedInfo[@]tevapharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia. Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. The total duration of participation in the trial for each participant is planned to be approximately 21 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the EOT or ET visit (ie, nonsmoking participants must agree not to start smoking and participants who smoke will be excluded if they plan to discontinue smoking during the trial period).
• Have a current confirmed diagnosis of schizophrenia according to an evaluation by the Investigator, as defined by the DSM-5 (American Psychiatric Association 2013a).
• Are clinically stable on oral olanzapine 20 mg daily (ie, dose has not changed in the last 4 weeks) and not currently on other antipsychotic treatments at the time of screening. Participants on alternative olanzapine regimens (eg, 10 mg twice daily) may be considered for inclusion in the trial based upon the Investigator's clinical judgment.
• Women may be included only if they have a negative serum beta human chorionic gonadotropin (HCG) test result at screening; they are surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (postmenopausal status will be confirmed by a follicle-stimulating hormone screen according to the clinical laboratory standard value) for at least 1 year; or they are practicing a highly effective method of birth control and not planning pregnancy for at least 30 days before the trial, for the duration of the trial, and for 70 days after the last dose administration, if they are sexually active and of childbearing potential.
• Men must be sterile; or if they are potentially of reproductive competence and have sexual relationship with female partners of childbearing potential, they must use, together with their female partners, highly effective birth control methods for the duration of the trial and for 70 days after the last dose administration. NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• History or known risk of narrow-angle glaucoma.
• History or a complication of diabetes (hemoglobin A1c 6.5% or above and/or fasting plasma glucose 126 mg/dL or above).
• Evidence of significant hepatic disorder.
• The participant is a pregnant or lactating woman or plans to become pregnant during the trial or within 70 days after the last dose administration.
• Known hypersensitivity or idiosyncratic reaction to olanzapine (or unable to tolerate oral olanzapine dose) or any of the excipients of TV-44749 in any formulation, their related compounds, or to any metabolites, or any compound listed as being present in TV-44749 or oral olanzapine.
• Presence of excessive pigment, bruises, scars, or tattoos around the potential injection area.
• Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, long QT syndrome, personal history of syncope, or history of uncontrolled high blood pressure. Participants with history of high blood pressure who no longer require treatment or participants who are treated with antihypertensive medications and whose blood pressure is currently well-controlled, may be enrolled.
• Substance use disorder criteria for alcohol, drug, or any other substance dependence (with the exception of nicotine or caffeine) have been met within the past 12 months prior to screening as defined by the DSM-5 (American Psychiatric Association 2013b).
• A current clinically significant DSM-5 diagnosis other than schizophrenia. NOTE- Additional criteria apply, please contact the investigator for more information

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• TV-44749
Administered subcutaneously (sc)
• Oral olanzapine
Administered orally

Locations

Country	Name	City	State
United States	Teva Investigational Site 15741	Atlanta	Georgia
United States	Teva Investigational Site 15742	Decatur	Georgia
United States	Teva Investigational Site 15738	Hollywood	Florida
United States	Teva Investigational Site 15739	Los Alamitos	California
United States	Teva Investigational Site 15737	Marlton	New Jersey
United States	Teva Investigational Site 15740	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of TV-44749		Days 57 to 84
Primary	AUC of oral olanzapine		24-hour period following administration of the 7th dose
Secondary	Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749		Days 1 to 113
Secondary	Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749		Days 1 to 113
Secondary	Number of participants with at least one injection site adverse event during treatment with TV-44749		Days 1 to 113
Secondary	Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749		Days 57 to 84
Secondary	Minimum observed plasma drug concentration at steady state (Cmin,ss) of TV-44749		Days 57 to 84
Secondary	Cmax,ss of oral olanzapine		24-hour period following administration of the 7th dose
Secondary	Cmin,ss of oral olanzapine		24-hour period following administration of the 7th dose