Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

Teva Branded Pharmaceutical Products R&D LLC24 enrolled

Overview

Primary Objective: To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use in Chinese participants with schizophrenia. Secondary Objectives: * To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc. * To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose administration. * To monitor the safety and tolerability of multiple doses of oral olanzapine tablets given in the study.

The total study duration for participants is planned to be approximately 13 weeks, including 40 days of screening, 1-week oral olanzapine treatment, a 1-week washout period, 4-week TV-44749 treatment, and 2-week follow-up period after the last dosing interval.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

TV-44749 318mgDRUG

Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection

Oral Olanzapine 10mg/dayDRUG

Pharmaceutical form: tablet Route of administration: oral

TV-44749 425mgDRUG

Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body weight \>50 kg and body mass index (BMI) between 18.5 to 38.0 kg/m2, inclusive, at the time of screening. * A current confirmed diagnosis of schizophrenia according to an evaluation by the investigator, using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Are clinically stable, on oral olanzapine (i.e., dose has not changed in the last 4 weeks), and not currently on other antipsychotic treatment at the time of screening. * No hospitalization for worsening of schizophrenic symptoms and no significant exacerbation of schizophrenic symptoms, as judged by the investigator, within the 3 months prior to screening. * Female participants must have a negative serum pregnancy test at screening, are sterile or postmenopausal, and not planning pregnancy within the study period and for an additional 6 months after last dose administration. * Male participants must be surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control. * Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the study until completion of the end of study (EOS)/early termination (ET) visit. * Have no ongoing or expected significant life events (such as pending loss of housing, marital status change, long travel abroad, surgery, etc.) that could affect study outcomes expected throughout the period of study participation. 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, musculoskeletal system or presence or history of clinically significant immunological, endocrine, metabolic, neurological, or psychiatric disorder(s) (other than schizophrenia), or a history of any illness that, in the opinion of the principal investigator, might pose additional risk to the participant by participation in the study or confound the results of the study * Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the investigational medicinal product (IMP), surgery scheduled during the study or follow-up period, or open biopsy within 4 months prior to screening * History of malignancy or treatment of malignancy in the last 5 years, excluding resected basal cell or squamous cell carcinoma of the skin. NOTE: Additional criteria apply, please contact the investigator for more information.

Locations (6)

Teva Investigational Site 88049

Beijing, China

Teva Investigational Site 88048

Beijing, China

Teva Investigational Site 88047

Guangzhou, China

Teva Investigational Site 88046

Shanghai, China

Outcomes

Primary Outcomes

Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all serious AEs (SAEs), regardless of causality is located in the Reported AE section.

Time frame: Day 1 Up to Day 43

Period 2: Number of Participants With Treatment Emergent SAEs

An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. 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. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section.

Time frame: Day 1 Up to Day 43

Period 2: Number of Participants With Injection Site AEs

Injection site AEs included injection site pruritus, induration, warmth, and abscess. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section. All injection site AEs are reported in this outcome measure and the AE module only reports non-serious AEs at the 5% threshold. In the AE module, a participant could have been included for multiple injection site AEs.

Time frame: Day 1 Up to Day 43

Secondary Outcomes

Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749

Data from ClinicalTrials.gov

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