NCT06315283

An Open-Label Trial to Assess the Comparative Bioavailability of TV-44749 to Oral Olanzapine in Participants With Schizophrenia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	TV-44749	Administered subcutaneously (sc)
DRUG	Oral olanzapine	Administered orally

Timeline

• Start date: 2024-03-20
• Primary completion: 2025-08-14
• Completion: 2025-09-04
• First posted: 2024-03-18
• Last updated: 2026-01-14

Locations

9 sites across 4 countries: United States, Croatia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study