Trial · NCT06319170
Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
NCT06319170, Phase 1, Completed, Teva Branded Pharmaceutical Products R&D LLC; results first posted 2026-01-26
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder. Trials, record NCT06319170. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06319170
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder
- NCT number
- NCT06319170
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 106 participants, actual
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Interventions
- Olanzapine Extended Release, Olanzapine Immediate Release
- First posted
- 2024-03-19
- Last updated
- 2026-01-26
- Results first posted
- 2026-01-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | |
| Primary | Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | |
| Primary | Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | |
| Secondary | 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 | Randomization Day 1 through Randomization Day 29 | 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. |
| Secondary | 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 | Randomization Day 1 through Randomization Day 29 | 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. |
| Secondary | Cmax of ZYPREXA (Immediate-release Formulation) | Up to 24 hours after administration of ZYPREXA (Day 4) | |
| Secondary | AUC0-t of ZYPREXA (Immediate-release Formulation) | Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13) | |
| Secondary | Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation) | Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | 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. | nanograms (ng)/milliliter (mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | 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. | hours*ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation) | Randomization Day 1 to 84 days after randomization | 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. | hours*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | 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 | Randomization Day 1 through Randomization Day 29 | The Safety Analysis Set included all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations). This outcome measure reports data for the participants who received one of the Olanzapine SC extended-release formulations only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Randomization Day 1 through Randomization Day 29 | The Safety Analysis Set included all participants who received at least 1 dose of study drug (ZYPREXA IM or one of the Olanzapine SC extended-release formulations). This outcome measure reports data for the participants who received one of the Olanzapine SC extended-release formulations only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cmax of ZYPREXA (Immediate-release Formulation) | Up to 24 hours after administration of ZYPREXA (Day 4) | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | AUC0-t of ZYPREXA (Immediate-release Formulation) | Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13) | 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. | hours*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Plasma Terminal Elimination Rate Constant (λz) of ZYPREXA (Immediate-release Formulation) | Predose (Day 4) up to 216 hours after administration of ZYPREXA (Day 13) | 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. | 1/hour | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) | Cohort 1: Olanzapine (Fast-D) | 39.26 | Geometric Coefficient of Variation 45.10 | nanograms (ng)/milliliter (mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) | Cohort 2: Olanzapine (To-be-marketed) | 35.62 | Geometric Coefficient of Variation 67.55 | nanograms (ng)/milliliter (mL) | |
| Maximum Observed Plasma Concentration (Cmax) of Olanzapine (Extended-release Formulation) | Cohort 3: Olanzapine (Slow-C) | 29.68 | Geometric Coefficient of Variation 50.13 | nanograms (ng)/milliliter (mL) | |
| Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation) | Cohort 1: Olanzapine (Fast-D) | 20994.08 | Geometric Coefficient of Variation 33.77 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation) | Cohort 2: Olanzapine (To-be-marketed) | 20185.90 | Geometric Coefficient of Variation 47.35 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve From Study Drug Administration to the Last Measurable Concentration (AUC0-t) of Olanzapine (Extended-release Formulation) | Cohort 3: Olanzapine (Slow-C) | 18461.94 | Geometric Coefficient of Variation 35.44 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation) | Cohort 1: Olanzapine (Fast-D) | 21703.07 | Geometric Coefficient of Variation 35.06 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation) | Cohort 2: Olanzapine (To-be-marketed) | 22146.09 | Geometric Coefficient of Variation 42.77 | hours*ng/mL | |
| Area Under the Plasma Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Olanzapine (Extended-release Formulation) | Cohort 3: Olanzapine (Slow-C) | 19011.66 | Geometric Coefficient of Variation 37.21 | hours*ng/mL | |
| 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 | Cohort 1: Olanzapine (Fast-D) | 9 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 1-Day Treatment Period | STARTED | ZYPREXA | 106 | |
| 1-Day Treatment Period | STARTED | Cohort 1: Olanzapine (Fast-D) | 0 | |
| 1-Day Treatment Period | STARTED | Cohort 2: Olanzapine (To-be-marketed) | 0 | |
| 1-Day Treatment Period | STARTED | Cohort 3: Olanzapine (Slow-C) | 0 | |
| 1-Day Treatment Period | Received at Least 1 Dose of Study Drug | ZYPREXA | 98 | |
| 1-Day Treatment Period | Received at Least 1 Dose of Study Drug | Cohort 1: Olanzapine (Fast-D) | 0 | |
| 1-Day Treatment Period | Received at Least 1 Dose of Study Drug | Cohort 2: Olanzapine (To-be-marketed) | 0 | |
| 1-Day Treatment Period | Received at Least 1 Dose of Study Drug | Cohort 3: Olanzapine (Slow-C) | 0 | |
| 1-Day Treatment Period | COMPLETED | ZYPREXA | 91 | |
| 1-Day Treatment Period | COMPLETED | Cohort 1: Olanzapine (Fast-D) | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events40
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site irritation | General disorders | ZYPREXA | 0 | 98 | 0 |
| other | Injection site irritation | General disorders | Cohort 1: Olanzapine (Fast-D) | 2 | 29 | 2 |
| other | Injection site irritation | General disorders | Cohort 2: Olanzapine (To-be-marketed) | 0 | 31 | 0 |
| other | Injection site irritation | General disorders | Cohort 3: Olanzapine (Slow-C) | 1 | 31 | 1 |
| other | Injection site pain | General disorders | ZYPREXA | 0 | 98 | 0 |
| other | Injection site pain | General disorders | Cohort 1: Olanzapine (Fast-D) | 2 | 29 | 2 |
| other | Injection site pain | General disorders | Cohort 2: Olanzapine (To-be-marketed) | 3 | 31 | 3 |
| other | Injection site pain | General disorders | Cohort 3: Olanzapine (Slow-C) | 0 | 31 | 0 |
| other | Urinary tract infection | Infections and infestations | ZYPREXA | 5 | 98 | 5 |
| other | Urinary tract infection | Infections and infestations | Cohort 1: Olanzapine (Fast-D) | 0 | 29 | 0 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ZYPREXA | 0 | 106 |
| Total, all-cause mortality | Cohort 1: Olanzapine (Fast-D) | 0 | 29 |
| Total, all-cause mortality | Cohort 2: Olanzapine (To-be-marketed) | 0 | 31 |
| Total, all-cause mortality | Cohort 3: Olanzapine (Slow-C) | 0 | 31 |
| Total, other adverse events | ZYPREXA | 18 | 98 |
| Total, other adverse events | Cohort 1: Olanzapine (Fast-D) | 8 | 29 |
| Total, other adverse events | Cohort 2: Olanzapine (To-be-marketed) | 11 | 31 |
| Total, other adverse events | Cohort 3: Olanzapine (Slow-C) | 6 | 31 |
| Total, serious adverse events | ZYPREXA | 0 | 98 |
| Total, serious adverse events | Cohort 1: Olanzapine (Fast-D) | 0 | 29 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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