NCT04567524

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Schizophrenia Schizoaffective

Interventions

Type	Name	Description
DRUG	LYN-005	LYN-005 (14 or 28 mg weekly) plus IR risperidone matched placebo.

Timeline

• Start date: 2020-08-13
• Primary completion: 2020-12-22
• Completion: 2020-12-22
• First posted: 2020-09-28
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study