Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia (NCT NCT06253546)
NCT ID: NCT06253546
Last Updated: 2026-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 Up to Day 43
Results posted on
2026-06-30
Participant Flow
A total of 36 participants were screened. Of these, 24 participants who met the eligibility criteria were enrolled and treated in Period 1 of the trial. A total of 21 participants who completed Period 1 were enrolled and treated in Period 2 of the trial.
Participant milestones
| Measure |
Period 1 Cohort 1: Olanzapine 10 mg/Day
Participants received oral olanzapine 10 milligrams (mg) once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 3: Olanzapine 20 mg/Day
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 2 Cohort 1: TV44749 318 mg
Participants received single dose of TV-44749 318 mg administered subcutaneously (SC) on Day 1.
|
Period 2 Cohort 2: TV44749 425 mg
Participants received single dose of TV-44749 425 mg administered SC on Day 1.
|
Period 2 Cohort 3: TV44749 531 mg
Participants received single dose of TV-44749 531 mg administered SC on Day 1.
|
|---|---|---|---|---|---|---|
|
Olanzapine Treatment & Washout (14 Days)
STARTED
|
12
|
6
|
6
|
0
|
0
|
0
|
|
Olanzapine Treatment & Washout (14 Days)
Received at Least 1 Dose of Study Drug
|
12
|
6
|
6
|
0
|
0
|
0
|
|
Olanzapine Treatment & Washout (14 Days)
COMPLETED
|
11
|
4
|
6
|
0
|
0
|
0
|
|
Olanzapine Treatment & Washout (14 Days)
NOT COMPLETED
|
1
|
2
|
0
|
0
|
0
|
0
|
|
TV-44749 Treatment & Follow-up (43 Days)
STARTED
|
0
|
0
|
0
|
11
|
4
|
6
|
|
TV-44749 Treatment & Follow-up (43 Days)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
11
|
4
|
6
|
|
TV-44749 Treatment & Follow-up (43 Days)
COMPLETED
|
0
|
0
|
0
|
11
|
4
|
6
|
|
TV-44749 Treatment & Follow-up (43 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Period 1 Cohort 1: Olanzapine 10 mg/Day
Participants received oral olanzapine 10 milligrams (mg) once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 3: Olanzapine 20 mg/Day
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 2 Cohort 1: TV44749 318 mg
Participants received single dose of TV-44749 318 mg administered subcutaneously (SC) on Day 1.
|
Period 2 Cohort 2: TV44749 425 mg
Participants received single dose of TV-44749 425 mg administered SC on Day 1.
|
Period 2 Cohort 3: TV44749 531 mg
Participants received single dose of TV-44749 531 mg administered SC on Day 1.
|
|---|---|---|---|---|---|---|
|
Olanzapine Treatment & Washout (14 Days)
Adverse Event
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Olanzapine Treatment & Washout (14 Days)
Other Than Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 12.82 • n=20 Participants
|
35.2 years
STANDARD_DEVIATION 11.30 • n=20 Participants
|
37.2 years
STANDARD_DEVIATION 12.61 • n=40 Participants
|
38.9 years
STANDARD_DEVIATION 12.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 Up to Day 43Population: The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
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.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
6 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 Up to Day 43Population: The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
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.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Number of Participants With Treatment Emergent SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 Up to Day 43Population: The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
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.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Number of Participants With Injection Site AEs
|
4 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 Up to Day 43Population: The pharmacokinetic (PK) analysis set for Period 2 included all participants who received a SC injection of TV-44749 and had sufficient data to calculate at least 1 PK parameter for TV-44749, where the participant had no events or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749
|
49.433 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 36.219
|
36.548 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 70.830
|
31.068 nanograms (ng)/milliliter (mL)
Geometric Coefficient of Variation 52.225
|
SECONDARY outcome
Timeframe: Day 1 Up to Day 43Population: The PK analysis set for Period 2 included all participants who received a SC injection of TV-44749 and had sufficient data to calculate at least 1 PK parameter for TV-44749, where the participant had no events or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Area Under the Plasma Drug Concentration-time Curve (AUC) Over the Period Following Administration on Day 1 to the Time of the Last Measurable Concentration (AUC0-t) of TV-44749
|
26848.490 hours*ng/mL
Geometric Coefficient of Variation 22.838
|
21267.510 hours*ng/mL
Geometric Coefficient of Variation 55.711
|
16873.205 hours*ng/mL
Geometric Coefficient of Variation 42.445
|
SECONDARY outcome
Timeframe: Day 1 Up to Day 43Population: The PK analysis set for Period 2 included all participants who received a SC injection of TV-44749 and had sufficient data to calculate at least 1 PK parameter for TV-44749, where the participant had no events or deviations that would affect calculation of parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=2 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=3 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: AUC of TV-44749 Over the Period Following Administration on Day 1 Extrapolated to Infinity (AUC0-inf)
|
30112.516 hours*ng/mL
Geometric Coefficient of Variation 21.029
|
28156.724 hours*ng/mL
Geometric Coefficient of Variation 67.333
|
21833.713 hours*ng/mL
Geometric Coefficient of Variation 53.378
|
SECONDARY outcome
Timeframe: Day 1 Up to Day 43Population: The PK analysis set for Period 2 included all participants who received a SC injection of TV-44749 and had sufficient data to calculate at least 1 PK parameter for TV-44749, where the participant had no events or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=4 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=11 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749
|
359.97 hours
Interval 264.02 to 408.05
|
227.73 hours
Interval 72.03 to 408.03
|
335.95 hours
Interval 72.07 to 551.85
|
SECONDARY outcome
Timeframe: Day 1 Up to Day 43Population: The PK analysis set for Period 2 included all participants who received a SC injection of TV-44749 and had sufficient data to calculate at least 1 PK parameter for TV-44749, where the participant had no events or deviations that would affect calculation of parameters. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=2 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=3 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 2: Apparent Elimination Half-Life (t½) of TV-44749
|
237.660 hours
Geometric Coefficient of Variation 16.514
|
152.664 hours
Geometric Coefficient of Variation 31.474
|
240.699 hours
Geometric Coefficient of Variation 69.523
|
SECONDARY outcome
Timeframe: Day -8Population: The PK analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine and had sufficient data to calculate at least 1 PK parameter for oral olanzapine, where the participant had no events of emesis (following oral olanzapine), other events, or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: Maximum Observed Plasma Drug Concentration at Steady State (Cmax,ss[Oral Olanzapine])
|
79.072 ng/mL
Geometric Coefficient of Variation 22.196
|
92.383 ng/mL
Geometric Coefficient of Variation 13.514
|
41.909 ng/mL
Geometric Coefficient of Variation 40.302
|
SECONDARY outcome
Timeframe: Day -8Population: The PK analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine and had sufficient data to calculate at least 1 PK parameter for oral olanzapine, where the participant had no events of emesis (following oral olanzapine), other events, or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: AUC of Oral Olanzapine From Time 0 to the End of the Dosing Interval (24 Hour) at Steady State (AUC0-tau,ss[Oral Olanzapine])
|
1362.093 hours*ng/mL
Geometric Coefficient of Variation 14.913
|
1412.857 hours*ng/mL
Geometric Coefficient of Variation 19.494
|
646.827 hours*ng/mL
Geometric Coefficient of Variation 39.875
|
SECONDARY outcome
Timeframe: Day -8 up to Day 20Population: The PK analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine and had sufficient data to calculate at least 1 PK parameter for oral olanzapine, where the participant had no events of emesis (following oral olanzapine), other events, or deviations that would affect calculation of parameters.
The steady-state AUC of oral olanzapine over a 28-day dosing interval was calculated by extrapolating the 24-hour AUC obtained following administration of the seventh oral dose (Day -8) to a 28-day period (AUC0-tau,ss\[oral olanzapine\] \* 28).
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: Calculated AUC of Oral Olanzapine at Steady State Extrapolated Over 28 Days (AUC0-tau,ss[Oral Olanzapine] * 28)
|
38138.590 hours*ng/mL
Geometric Coefficient of Variation 14.913
|
39559.991 hours*ng/mL
Geometric Coefficient of Variation 19.494
|
18111.151 hours*ng/mL
Geometric Coefficient of Variation 39.875
|
SECONDARY outcome
Timeframe: Day -8Population: The PK analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine and had sufficient data to calculate at least 1 PK parameter for oral olanzapine, where the participant had no events of emesis (following oral olanzapine), other events, or deviations that would affect calculation of parameters.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=4 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: Time to Maximum Concentration of Oral Olanzapine at Steady State (Tmax,ss[Oral Olanzapine])
|
3.03 hours
Interval 1.0 to 4.98
|
2.00 hours
Interval 2.0 to 3.0
|
2.00 hours
Interval 1.03 to 3.0
|
SECONDARY outcome
Timeframe: Day -14 up to Day -8Population: The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine.
An 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 SAEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: Number of Participants With TEAEs
|
6 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day -14 up to Day -8Population: The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine.
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-SAEs and all serious AEs, regardless of causality is located in the Reported AE section.
Outcome measures
| Measure |
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 Participants
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 Participants
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 Participants
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
|---|---|---|---|
|
Period 1: Number of Participants With Treatment Emergent SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Period 1 Cohort 1: Olanzapine 10 mg/Day
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Period 1 Cohort 2: Olanzapine 15 mg/Day
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 1 Cohort 3: Olanzapine 20 mg/Day
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 2 Cohort 1: TV44749 318 mg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Period 2 Cohort 2: TV44749 425 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2 Cohort 3: TV44749 531 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 participants at risk
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 participants at risk
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 participants at risk
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 2 Cohort 1: TV44749 318 mg
n=11 participants at risk
Participants received single dose of TV-44749 318 mg administered SC on Day 1.
|
Period 2 Cohort 2: TV44749 425 mg
n=4 participants at risk
Participants received single dose of TV-44749 425 mg administered SC on Day 1.
|
Period 2 Cohort 3: TV44749 531 mg
n=6 participants at risk
Participants received single dose of TV-44749 531 mg administered SC on Day 1.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
Other adverse events
| Measure |
Period 1 Cohort 1: Olanzapine 10 mg/Day
n=12 participants at risk
Participants received oral olanzapine 10 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 2: Olanzapine 15 mg/Day
n=6 participants at risk
Participants received oral olanzapine 15 mg once daily for 7 days (Day -14 to Day -8).
|
Period 1 Cohort 3: Olanzapine 20 mg/Day
n=6 participants at risk
Participants received oral olanzapine 20 mg once daily for 7 days (Day -14 to Day -8).
|
Period 2 Cohort 1: TV44749 318 mg
n=11 participants at risk
Participants received single dose of TV-44749 318 mg administered SC on Day 1.
|
Period 2 Cohort 2: TV44749 425 mg
n=4 participants at risk
Participants received single dose of TV-44749 425 mg administered SC on Day 1.
|
Period 2 Cohort 3: TV44749 531 mg
n=6 participants at risk
Participants received single dose of TV-44749 531 mg administered SC on Day 1.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular conduction time shortened
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Cardiac disorders
Sinus bradycardia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Endocrine disorders
Hyperprolactinaemia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
General disorders
Fatigue
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
18.2%
2/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
General disorders
Injection site induration
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
18.2%
2/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
General disorders
Injection site warmth
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
27.3%
3/11 • Number of events 3 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
18.2%
2/11 • Number of events 3 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood glucose increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood pressure increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood prolactin abnormal
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Blood prolactin increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Heart rate increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Platelet count decreased
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Weight decreased
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Investigations
Weight increased
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
18.2%
2/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
25.0%
1/4 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
27.3%
3/11 • Number of events 3 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
45.5%
5/11 • Number of events 6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
25.0%
1/4 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
9.1%
1/11 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
25.0%
1/4 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • Number of events 3 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
33.3%
2/6 • Number of events 2 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Psychiatric disorders
Schizophrenia
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
25.0%
1/4 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
8.3%
1/12 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
16.7%
1/6 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/4 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
|
Vascular disorders
Hypotension
|
0.00%
0/12 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/11 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
25.0%
1/4 • Number of events 1 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
0.00%
0/6 • Period 1: Day -14 up to Day -8; Period 2: Day 1 up to Day 43
The safety analysis set for Period 1 included all participants who received at least 1 dose of oral olanzapine. The safety analysis set for Period 2 included all participants who received a SC injection of TV-44749.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D LLC
Phone: 888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER