Trial TV-44749 in participants with Schizophrenia (Prolonged-release Olanzapine)
Research type
Research Study
Full title
A 21-Week, Multicenter, Open-Label, Multiple-Dose Trial to Assess the Comparative Bioavailability of Olanzapine Prolonged-Release Suspension for Subcutaneous Administration (TV-44749) to Oral Olanzapine (European Reference) in Participants with Schizophrenia
IRAS ID
1009410
Contact name
Udo Hartlaub
Contact email
Sponsor organisation
Teva Branded Pharmaceutical Products R&D, Inc.
Research summary
Schizophrenia is a severely debilitating psychotic disorder. It is characterised by delusions, hallucinations, disorganised behaviour and total lack of motivation.
The purpose of this research study is to compare the bioavailability (ability of a medicine to be absorbed and used by the body) of TV-44749, an investigational medicine administered subcutaneously (under the skin), to the bioavailability of oral olanzapine tablets, in adults with schizophrenia. The study will determine how safe and well tolerated multiple doses of TV-44749 and oral olanzapine are in adults with schizophrenia.
TV-44749 is a drug that is an extended-release (released slowly over time) form of olanzapine that is given by subcutaneous injection (an injection of drug just under the skin). Olanzapine is approved for oral use (brand name Zyprexa®) for schizophrenia in the United States, the United Kingdom and the European Union (EU) for the treatment of adults and adolescents with schizophrenia.
Participants will receive oral olanzapine once daily for 7 days during Treatment Period 1. They will take one 20 mg tablet with a glass of water each day for 7 days during the treatment period.
In Treatment Period 2, participants will receive TV-44749, administered as a subcutaneous injection into the skin of the abdomen once a month for 3 consecutive months, on Day 1, Day 29 and Day 57. During treatment period 2 the participants will receive the study drug as inpatients in hospital to allow for better safety monitoring.
Participants will be in the study for around 21 weeks. There will be 18 outpatient visits, 4 hospital admissions and up to 7 phone calls from the study staff.
Approximately 116 participants will take part in the study in Europe and the United States.
Study procedures will include blood tests, ECGs, physical examinations and recording of vital signs.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0130
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Favourable Opinion