Schizophrenia, Schizoaffective DisorderPhase 1NCT06319170

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

A Phase 1 study testing Olanzapine Extended Release and Olanzapine Immediate Release in people with Schizophrenia, Schizoaffective Disorder, run by Teva Branded Pharmaceutical Products R&D LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Olanzapine Extended Release and Olanzapine Immediate Release
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: 5 sitesUnited States
Study dates: 28 Mar 2024to 20 Jan 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Teva Investigational Site 15729
Atlanta, Georgia, 30331
Teva Investigational Site 15728
Decatur, Georgia, 30030
Teva Investigational Site 15727
Hollywood, Florida, 33024
Teva Investigational Site 15730
Los Alamitos, California, 90720
Teva Investigational Site 15726
Marlton, New Jersey, 08053

Other trials in United States

About this study

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

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.

Read the detailed description

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

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Olanzapine Extended Release, Olanzapine Immediate Release
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Olanzapine Extended ReleaseDrug
Powder and vehicle for injectable suspension
Olanzapine Immediate ReleaseDrug
Also called ZYPREXA
IntraMuscular Injection

Study groups in NCT06319170
Study group	Role	What they receive
Olanzapine (Fast-D) 425mg	Experimental	Single-dose injection Receives: Drug: Olanzapine Extended Release
Olanzapine (To-be-marketed) 425mg	Experimental	Single-dose injection Receives: Drug: Olanzapine Extended Release
Olanzapine (Slow-C) 425mg	Experimental	Single-dose injection Receives: Drug: Olanzapine Extended Release
ZYPREXA 5mg	Experimental	Single-dose injection Receives: Drug: Olanzapine Immediate Release

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
Measured: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
Measured: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
Measured: Randomization Day 1 to 84 days after randomization

Secondary outcomes (5)

Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
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. A TEAE was defined as an AE that occurred after the first dose of study drug administration through the end of trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Randomization Day 1 through Randomization Day 29
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
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. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Randomization Day 1 through Randomization Day 29
Cmax of ZYPREXA (Immediate-release Formulation)
Measured: Up to 24 hours after administration of ZYPREXA (Day 4)
AUC0-t of ZYPREXA (Immediate-release Formulation)
Measured: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)
Measured: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202420 Jan 2025

First posted19 Mar 2024
Study start28 Mar 2024
Primary completion15 Jan 2025
Study completion20 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Schizophrenia, Schizoaffective DisorderStudies of the same condition, open and under way.
More trials run by Teva Branded Pharmaceutical Products R&D LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06319170
Sponsor's protocol ID: TV44749-NPC-10205
Status last verified: Dec 2025
First submitted: 13 Mar 2024
Last updated: 26 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
Schizophrenia, Schizoaffective Disorder

All Schizophrenia, Schizoaffective Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06319170
Acronym / sponsor ID: TV44749-NPC-10205
Conditions: Schizophrenia, Schizoaffective Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
Study start: 28 Mar 2024 (actual)
Primary completion: 15 Jan 2025 (actual)
Study completion: 20 Jan 2025 (actual)
First posted: 19 Mar 2024 (actual)
Results: Posted 26 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Olanzapine (Fast-D) 425mg	Experimental	Drug: Olanzapine Extended ReleaseSingle-dose injection
Olanzapine (To-be-marketed) 425mg	Experimental	Drug: Olanzapine Extended ReleaseSingle-dose injection
Olanzapine (Slow-C) 425mg	Experimental	Drug: Olanzapine Extended ReleaseSingle-dose injection
ZYPREXA 5mg	Experimental	Drug: Olanzapine Immediate ReleaseSingle-dose injection

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Olanzapine Extended ReleasePowder and vehicle for injectable suspension	Drug	Olanzapine (Fast-D) 425mg, Olanzapine (Slow-C) 425mg, Olanzapine (To-be-marketed) 425mg
Olanzapine Immediate ReleaseAlso: ZYPREXAIntraMuscular Injection	Drug	ZYPREXA 5mg

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization
Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)
Time frame: Randomization Day 1 to 84 days after randomization

5 secondary outcomes

Number of Participants With at Least 1 Treatment-emergent Adverse Event (TEAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
Time frame: Randomization Day 1 through Randomization Day 29
Number of Participants With at Least 1 Serious Adverse Event (SAE) Over the 28-day Period Following Administration of 1 of the SC Olanzapine Formulations
Time frame: Randomization Day 1 through Randomization Day 29
Cmax of ZYPREXA (Immediate-release Formulation)
Time frame: Up to 24 hours after administration of ZYPREXA (Day 4)
AUC0-t of ZYPREXA (Immediate-release Formulation)
Time frame: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)
Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation)
Time frame: Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13)

Results and safety

Results posted to the registry on 26 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZYPREXA	106	91
Cohort 1: Olanzapine (Fast-D)	0	0
Cohort 2: Olanzapine (To-be-marketed)	0	0
Cohort 3: Olanzapine (Slow-C)	0	0

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation)

Time frame: Randomization Day 1 to 84 days after randomization. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms (ng)/milliliter (mL)

Measure	Cohort 1: Olanzapine (Fast-D) n = 29	Cohort 2: Olanzapine (To-be-marketed) n = 28	Cohort 3: Olanzapine (Slow-C) n = 31
Value	39.26 (45.10)	35.62 (67.55)	29.68 (50.13)

Population analysed: The Pharmacokinetic (PK) Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation)

Time frame: Randomization Day 1 to 84 days after randomization. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	Cohort 1: Olanzapine (Fast-D) n = 27	Cohort 2: Olanzapine (To-be-marketed) n = 26	Cohort 3: Olanzapine (Slow-C) n = 30
Value	20994.08 (33.77)	20185.90 (47.35)	18461.94 (35.44)

Population analysed: The PK Analysis Set included all participants who had sufficient data to calculate at least 1 PK parameter for any of the olanzapine formulations (IM immediate release or SC extended release) and had no intercurrent events or deviations that affected the calculation of PK parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation)

Time frame: Randomization Day 1 to 84 days after randomization. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	Cohort 1: Olanzapine (Fast-D) n = 24	Cohort 2: Olanzapine (To-be-marketed) n = 23	Cohort 3: Olanzapine (Slow-C) n = 27
Value	21703.07 (35.06)	22146.09 (42.77)	19011.66 (37.21)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 84. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZYPREXA	0 of 98 (0%)	18 of 98 (18.4%)	0 of 106
Cohort 1: Olanzapine (Fast-D)	0 of 29 (0%)	8 of 29 (27.6%)	0 of 29
Cohort 2: Olanzapine (To-be-marketed)	1 of 31 (3.2%)	11 of 31 (35.5%)	0 of 31
Cohort 3: Olanzapine (Slow-C)	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit USMedInfo@tevapharm.com to make your request.

Related trials for Schizophrenia, Schizoaffective Disorder

Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Recruiting
Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3
Schizophrenia / Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Not yet recruiting
Integrated Psychoeducation Program for Internalized Stigma in Schizophrenia
Schizophrenia, Schizoaffective Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Teva Medical Expert, MD study director

Teva Branded Pharmaceutical Products R&D, Inc.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) (time frame: Randomization Day 1 to 84 days after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06319170.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.