A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules

Schizophrenia Schizoaffective Clinical Trial

Official title: A Multiple Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Risperidone Extended Release Capsules in Subjects With Schizophrenia, Schizoaffective Disorder

Status Completed

Clinical Trial Summary

Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005) presented in a capsule dosage form with the intent of reducing the frequency of dosing orally-administered medications to once weekly or less and thereby improving the management of schizophrenia. Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to IR risperidone.

Clinical Trial Description

LYN-005-C-004 is a blinded, multiple-dose, randomized, parallel group, safety, tolerability and PK study of LYN-005 in subjects with a primary diagnosis of schizophrenia or schizoaffective disorder in general good health. Eligible subjects must be clinically stable and receiving a therapeutic dose of an approved oral antipsychotic drug for a minimum of 6 weeks at the time of Screening. Enrolled subjects will be evaluated under steady-state conditions on commercially-available IR risperidone tablets and then assigned in blinded fashion either to LYN-005 weekly or continued encapsulated IR risperidone daily for 3 weeks to attain (or continue) steady-state exposure. ;

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia Schizoaffective

• NCT number: NCT04567524
• Study type: Interventional
• Source: Lyndra Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 13, 2020
• Completion date: December 22, 2020