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

Schizophrenia, Schizoaffective Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319170
• Other study ID #: TV44749-NPC-10205
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: December 11, 2024

Study information

• Verified date: June 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 11, 2024
• Est. primary completion date: December 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia
• Schizophrenia, Schizoaffective Disorder

Intervention

Drug:
• Olanzapine Extended Release
Powder and vehicle for injectable suspension
• Olanzapine
IntraMuscular Injection

Locations

Country	Name	City	State
United States	Teva Investigational Site 15729	Atlanta	Georgia
United States	Teva Investigational Site 15728	Decatur	Georgia
United States	Teva Investigational Site 15727	Hollywood	Florida
United States	Teva Investigational Site 15730	Los Alamitos	California
United States	Teva Investigational Site 15726	Marlton	New Jersey

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	Maximum observed plasma drug concentration (Cmax)		Randomization to 84 days after randomization
Primary	Area under the plasma drug concentration-time curve (AUC)		Randomization to 84 days after randomization
Primary	AUC extrapolated to infinity (AUC0-8)		Randomization to 84 days after randomization
Secondary	Number of participants with at least 1 treatment-emergent adverse event (TEAE)		Randomization to 29 days after randomization
Secondary	Number of participants with at least 1 serious adverse event (SAE)		Randomization to 29 days after randomization
Secondary	Cmax of ZYPREXA		Up to 24 hours after administration of ZYPREXA
Secondary	AUC of ZYPREXA		Up to 216 hours after administration of ZYPREXA
Secondary	Apparent plasma terminal elimination rate constant (?z) of ZYPREXA		Up to 216 hours after administration of ZYPREXA