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

NCT06319170 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: TV44749-NPC-10205
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Schizophrenia, Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

  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

  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)

Study Arms (4)

Olanzapine (Fast-D) 425mg

EXPERIMENTAL

Single-dose injection

Drug: Olanzapine Extended Release

Olanzapine (To-be-marketed) 425mg

EXPERIMENTAL

Single-dose injection

Drug: Olanzapine Extended Release

Olanzapine (Slow-C) 425mg

EXPERIMENTAL

Single-dose injection

Drug: Olanzapine Extended Release

ZYPREXA 5mg

EXPERIMENTAL

Single-dose injection

Drug: Olanzapine Immediate Release

Interventions

Olanzapine Extended Release DRUG

Powder and vehicle for injectable suspension

Olanzapine (Fast-D) 425mg; Olanzapine (Slow-C) 425mg; Olanzapine (To-be-marketed) 425mg

Olanzapine Immediate Release DRUG

IntraMuscular Injection

Also known as: ZYPREXA

ZYPREXA 5mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (5)

Teva Investigational Site 15730

Los Alamitos, California, 90720, United States

Location

Teva Investigational Site 15727

Hollywood, Florida, 33024, United States

Location

Teva Investigational Site 15729

Atlanta, Georgia, 30331, United States

Location

Teva Investigational Site 15728

Decatur, Georgia, 30030, United States

Location

Teva Investigational Site 15726

Marlton, New Jersey, 08053, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D LLC

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: March 28, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 20, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (5)