Clinical trial NCT06319170: Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia, Schizoaffective Disorder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-19
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: Randomization to 84 days after randomization
measure: Area under the plasma drug concentration-time curve (AUC)
timeFrame: Randomization to 84 days after randomization
measure: AUC extrapolated to infinity (AUC0-∞)
timeFrame: Randomization to 84 days after randomization
Secondary outcomes:
measure: Number of participants with at least 1 treatment-emergent adverse event (TEAE)
timeFrame: Randomization to 29 days after randomization
measure: Number of participants with at least 1 serious adverse event (SAE)
timeFrame: Randomization to 29 days after randomization
measure: Cmax of ZYPREXA
timeFrame: Up to 24 hours after administration of ZYPREXA
measure: AUC of ZYPREXA
timeFrame: Up to 216 hours after administration of ZYPREXA
measure: Apparent plasma terminal elimination rate constant (λz) of ZYPREXA
timeFrame: Up to 216 hours after administration of ZYPREXA
Other outcomes:
Locations:
city: Los Alamitos
country: United States
facility: Teva Investigational Site 15730
state: California
city: Hollywood
country: United States
facility: Teva Investigational Site 15727
state: Florida
city: Atlanta
country: United States
facility: Teva Investigational Site 15729
state: Georgia
city: Decatur
country: United States
facility: Teva Investigational Site 15728
state: Georgia
city: Marlton
country: United States
facility: Teva Investigational Site 15726
state: New Jersey
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: