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

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.

Timeline

Start

2020-08-13

Primary completion

2020-12-22

Completion

2020-12-22

Drugs

Indications