Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder

A Multi-center, Open-label, Randomized, Parallel-group Trial to Characterize the Pharmacokinetics of Three SC Olanzapine Extended-release Formulations With Different Release Rates Following Single Administration in Participants With Schizophrenia or Schizoaffective Disorder

The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.

A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.

Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.

The planned duration of the study for each participant is 19 weeks.

Study Overview

• Status: Completed
• Conditions: Schizophrenia, Schizoaffective Disorder
• Intervention / Treatment: Drug: Olanzapine Extended Release; Drug: Olanzapine Immediate Release

Detailed Description

All participants received immediate-release ZYPREXA and then were randomized into 1 of 3 extended-release olanzapine formulations.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Teva Investigational Site 15730
  • Florida
    • Hollywood, Florida, United States, 33024
      • Teva Investigational Site 15727
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Teva Investigational Site 15729
    • Decatur, Georgia, United States, 30030
      • Teva Investigational Site 15728
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Teva Investigational Site 15726

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body weight >50 kg and body mass index (BMI) within the range 18.5 to 38.0 kg/m2, inclusive, at the time of screening
• Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the trial until completion of the end of treatment or early termination (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
• Agree to the inpatient periods required during the trial period
• Have a current confirmed diagnosis of schizophrenia or schizoaffective disorder according to an evaluation by the Investigator, using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association 2013a)
• Have no ongoing or expected significant life events (eg, pending loss of housing, marital status change, long travel abroad, surgery) that could affect trial outcomes throughout the period of trial participation
• 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
• 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:

• Presence or have a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, or musculoskeletal system, or presence or history of clinically significant immunological, endocrine, or metabolic diseases, neurological or psychiatric disorder(s) (other than schizophrenia)
• History or known risk of narrow-angle glaucoma
• Uncontrolled diabetes
• Major trauma or surgery in the 2 months before screening
• History of malignancy or treatment of malignancy in the last 5 years, excluding resected basal cell or squamous cell carcinoma of the skin
• 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
• 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

NOTE- Additional criteria apply, please contact the investigator for more information

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olanzapine (Fast-D) 425mg; Single-dose injection	Drug: Olanzapine Extended Release; Powder and vehicle for injectable suspension
Experimental: Olanzapine (To-be-marketed) 425mg; Single-dose injection	Drug: Olanzapine Extended Release; Powder and vehicle for injectable suspension
Experimental: Olanzapine (Slow-C) 425mg; Single-dose injection	Drug: Olanzapine Extended Release; Powder and vehicle for injectable suspension
Experimental: ZYPREXA 5mg; Single-dose injection	Drug: Olanzapine Immediate Release; IntraMuscular Injection; Other Names: ZYPREXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)	Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)	Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)	Randomization Day 1 to 84 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations	An adverse event (AE) was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A TEAE was defined as an AE that occurred after the first dose of study drug administration through the end of trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.	Randomization Day 1 through Randomization Day 29
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations	The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.	Randomization Day 1 through Randomization Day 29
Cmax of ZYPREXA (Immediate-release Formulation)		Up to 24 hours after administration of ZYPREXA (Day 4)
AUC0-t of ZYPREXA (Immediate-release Formulation)		Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)		Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D LLC
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Psychotic Disorders; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Olanzapine
• Other Study ID Numbers: TV44749-NPC-10205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

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