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

NCT04567524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-02-08

Study results available
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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.

Conditions

  • Schizophrenia Schizoaffective

Interventions

DRUG

LYN-005

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

Sponsors & Collaborators

  • Worldwide Clinical Trials

    collaborator OTHER

  • Lyndra Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Scranton, MD, MPH · Chief Medical Officer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2020-12-22
Completion
2020-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567524 on ClinicalTrials.gov