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

NCT05779241 | Completed Phase 3 FDA Drug

• 1 other identifier: LYN 005-C-301
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (4)

• Minimum Observed Concentration (Cmin) at Week 1

  up to Day 36

• Minimum Observed Concentration (Cmin) at Week 5

  up to Day 36

• Maximal Observed Concentration (Cmax) at Week 5

  up to Day 36

• Average Concentration Over the Dosing Interval (Cavg) at Week 5

  up to Day 36

Secondary Outcomes (2)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) From Week 1 to Week 5

  Week 1 to Week 5

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) to Week 5

  Baseline, up to Week 5

Study Arms (2)

LYN-005 Containing 15-mg Risperidone

EXPERIMENTAL

During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period, participants receive 5 weekly doses of LYN-005 15 mg (Days 1, 8, 15, 22, and 29) and Risperdal 1 mg from Day 1 to Day 7.

Drug: LYN-005; Drug: Risperidone

LYN-005 Containing 45-mg Risperidone

EXPERIMENTAL

During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period participants receive 5 weekly doses of LYN-005 45 mg (Days 1, 8, 15, 22, and 29) and Risperdal 3 mg from Day 1 to Day 7.

Drug: LYN-005; Drug: Risperidone

Interventions

LYN-005 DRUG

Risperidone long-acting oral capsule

LYN-005 Containing 15-mg Risperidone; LYN-005 Containing 45-mg Risperidone

Risperidone DRUG

Risperidone immediate release (IR) oral tablets

Also known as: Risperdal

LYN-005 Containing 15-mg Risperidone; LYN-005 Containing 45-mg Risperidone

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged ≥18 and ≤64 years.
• Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview for Psychotic Disorder Studies (MINI) version 7.0.2.
• The following psychiatric criteria are to be used to determine participant eligibility:
• Duration of diagnosis of schizophrenia or schizoaffective disorder of ≥2 years.
• Outpatient; not hospitalized for worsening of schizophrenia within the last 6 months (partial hospitalization for social management within this time period is acceptable).
• Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months.
• Stabilized on an oral antipsychotic medication (single agent) for a minimum of 6 weeks at the time of Screening.
• On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month before the Screening visit and for the duration of the study.
• Clinical Global Impression-Severity (CGI-S) score of ≤4 (moderately ill) at screening.
• PANSS score of ≤80 points at screening.
• Body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2.
• Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
• Willing to comply with all protocol-specified procedures and availability for the duration of the study.

You may not qualify if:

• Participants with known clinically significant esophageal or gastrointestinal (GI) disease, including but not limited to:
• Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or participants with high risk of stricture, eg, Crohn's disease.
• Diagnosis of a condition known to elevate or lower gastric pH, eg, achlorhydria or hypochlorhydria.
• Prior varices or small or large bowel obstructions.
• Prior abdominal or upper gastrointestinal surgery (prior uncomplicated laparoscopic procedures including appendectomy or colectomy are permitted).
• History of dysphagia or aspiration in the last 5 years.
• History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder.
• Significant history of diarrhea or constipation within 3 months of Screening. For constipation, 2 or more of the following in the preceding 12 months (the episodes need not be consecutive): i. Straining \>1/4 of defecations; ii. Lumpy or hard stools \>1/4 of defecations; iii. Sensation of incomplete evacuation \>1/4 of defecations; iv. Sensation of anorectal obstruction/blockage \>1/4 of defecations; v .Manual maneuvers to facilitate \>1/4 of defecations (e.g., digital evacuation, support of the pelvic floor); vi.\<3 defecations per week; vii. Loose stools are not present, and there are insufficient criteria for irritable bowel syndrome.
• Multiple episodes of abdominal pain within 3 months of Screening.
• Moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) within 3 months of Screening.
• History of moderate to severe Acid Reflux Disease or a score of ≥2 on the Acid Reflux Severity Scale (ARSS) \[2\] , indicating moderate to severe symptoms.
• PILL-5 questionnaire score of 5 or greater.
• Medical history or current diagnoses indicating the presence of any of the below conditions:
• Presence of an uncontrolled, unstable, clinically significant medical condition that could put the participant at risk because of participation in the study, interfere with the participant's ability to participate in the study or influence the interpretation of safety or PK evaluations.
• History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure with 6 months of Screening.

Sponsors & Collaborators

• Lyndra Inc.: lead

Study Sites (5)

CenExel CNS

Garden Grove, California, 92845, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Uptown Research Institute

Chicago, Illinois, 60640, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

Related Publications (1)

• Citrome L, Nagaraj N, Traverso G, Dumas T, Scranton R. Long-acting oral weekly risperidone (LYN-005) for schizophrenia in the USA (STARLYNG-1): a multicentre, open-label, non-randomised phase 3 trial. Lancet Psychiatry. 2025 Jul;12(7):504-512. doi: 10.1016/S2215-0366(25)00135-X.

  PMID: 40506209 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Scranton, MD, MPH

  Lyndra Therapeutics INC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: April 13, 2023
• Primary Completion: November 3, 2023
• Study Completion: December 1, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)