NCT05779241

Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005

A Multi Dose, Open-Label, Parallel-Group Study to Evaluate the PK and Safety/Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Lyndra Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

Lyndra Therapeutics, Inc. is developing LYN-005, a long-acting oral (LAO) capsule (LYNX™ dosage form) of risperidone. This pivotal study (LYN-005-C-301) will evaluate the PK as well as safety and tolerability of multiple administrations of the LYN-005 formulation at two dose levels.

Conditions

• Schizophrenia
• Schizoaffective Disorder

Interventions

Type	Name	Description
DRUG	LYN-005	Risperidone long-acting oral capsule
DRUG	Risperidone	Risperidone immediate release (IR) oral tablets

Timeline

• Start date: 2023-04-13
• Primary completion: 2023-11-03
• Completion: 2023-12-01
• First posted: 2023-03-22
• Last updated: 2024-10-24

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study