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

Teva Branded Pharmaceutical Products R&D LLC

Status and phase: Completed; Phase 1

Conditions: Schizophrenia, Schizoaffective Disorder

Treatments: Drug: Olanzapine Extended Release; Drug: Olanzapine Immediate Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT06319170

TV44749-NPC-10205

Details and patient eligibility

About

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.

Full description

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

Enrollment: 106 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 4 patient groups

Olanzapine (Fast-D) 425mg

Experimental group

Description:

Single-dose injection

Treatment:

Drug: Olanzapine Extended Release

Olanzapine (To-be-marketed) 425mg

Experimental group

Description:

Single-dose injection

Treatment:

Drug: Olanzapine Extended Release

Olanzapine (Slow-C) 425mg

Experimental group

Description:

Single-dose injection

Treatment:

Drug: Olanzapine Extended Release

ZYPREXA 5mg

Experimental group

Description:

Single-dose injection

Treatment:

Drug: Olanzapine Immediate Release