Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
Phase 1
Active, not recruiting
- Conditions
- Schizophrenia
- Interventions
- Registration Number
- NCT06253546
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine Dose 1 Oral Olanzapine Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive subcutaneous (sc) injection of TV-44749 Olanzapine Dose 1 TV-44749 Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive subcutaneous (sc) injection of TV-44749 Olanzapine Dose 2 Oral Olanzapine Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 Olanzapine Dose 3 Oral Olanzapine Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 Olanzapine Dose 3 TV-44749 Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 Olanzapine Dose 2 TV-44749 Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749
- Primary Outcome Measures
Name Time Method Period 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs) Day 1 Up to Day 43 Period 2: Number of Participants with Treatment Emergent Serious Adverse Events (SAEs) Day 1 Up to Day 43 Period 2: Number of Participants with Injection Site Adverse Events Day 1 Up to Day 43
- Secondary Outcome Measures
Name Time Method Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749 Day 1 Up to Day 43 Period 2: Apparent Elimination Half-Life (t½) of TV-44749 Day 1 Up to Day 43 Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749 Day 1 Up to Day 43 Period 2: Area Under the Plasma Drug Concentration versus Time Curve (AUC) of TV-44749 Day 1 Up to Day 43 Period 2: AUC of TV-44749 Extrapolated to Infinity (AUC0-∞) Day 1 Up to Day 43 Period 1: Number of Participants with TEAEs Day 1 Up to Day 7 Period 1: Time to Maximum Concentration of Oral Olanzapine at Steady State (Tmax,ss[oral olanzapine]) Day 7 Period 1: AUC of Oral Olanzapine at Steady State (AUC0-τ,ss[oral olanzapine]) Day 7 Period 1: Calculated AUC of Oral Olanzapine at Steady State Extrapolated Over 28 Days (AUC0-τ,ss[oral olanzapine] × 28) Day 7 Period 1: Number of Participants with Treatment Emergent SAEs Day 1 Up to Day 7 Period 1: Maximum Observed Plasma Drug concentration at Steady State (Cmax,ss[oral olanzapine]) Day 7
Trial Locations
- Locations (6)
Teva Investigational Site 88056
🇨🇳Xi'an Shi, China
Teva Investigational Site 88046
🇨🇳Shanghai, China
Teva Investigational Site 88050
🇨🇳Wuhan Shi, China
Teva Investigational Site 88049
🇨🇳Beijing, China
Teva Investigational Site 88048
🇨🇳Beijing, China
Teva Investigational Site 88047
🇨🇳Guangzhou, China