The primary objective of the study is to evaluate the comparative bioavailability of TV-44749 administered subcutaneous (sc) to oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. A secondary objective of this trial is to evaluate the safety and tolerability of multiple doses of TV-44749 administered sc in participants with schizophrenia. Another secondary objective of this trial is to compare additional pharmacokinetic parameters of TV-44749 administered sc with oral olanzapine (ZYPREXA®) at steady state in participants with schizophrenia. The total duration of participation in the trial for each participant is planned to be approximately 21 weeks.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Administered subcutaneously (sc)
Administered orally
Teva Investigational Site 15739
Los Alamitos, California, United States
Teva Investigational Site 15740
Torrance, California, United States
Teva Investigational Site 15738
Hollywood, Florida, United States
Teva Investigational Site 15741
Atlanta, Georgia, United States
Teva Investigational Site 15742
Decatur, Georgia, United States
Teva Investigational Site 15737
Marlton, New Jersey, United States
Teva Investigational Site 60053
Zagreb, Croatia
Teva Investigational Site 31326
Zamora, Spain
Teva Investigational Site 34310
Surrey, United Kingdom
Area under the curve (AUC) of TV-44749
Time frame: Days 57 to 85
AUC of oral olanzapine
Time frame: 24-hour period following administration of the 7th dose
Number of participants with at least one treatment-emergent adverse event during treatment with TV-44749
Time frame: Days 1 to 113
Number of participants with at least one treatment-emergent serious adverse event during treatment with TV-44749
Time frame: Days 1 to 113
Number of participants with at least one injection site adverse event during treatment with TV-44749
Time frame: Days 1 to 113
Maximum observed plasma drug concentration at steady state (Cmax,ss) of TV-44749
Time frame: Day 57 to Day 85
Plasma concentration at the end of the dosing interval at steady state (Ctrough,ss) of TV-44749
Time frame: Day 85
Cmax,ss of oral olanzapine
Time frame: 24-hour period following administration of the 7th dose
Ctrough,ss of oral olanzapine
Time frame: 24-hour period following administration of the 7th dose
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