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

Completed · Phase 3

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID: NCT05779241
Run by: Lyndra Inc.
People needed: 83
Starts: 2023-04-13
Expected to finish: 2023-12-01
Last updated by the study team: 2024-10-24

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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.
Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
Known immunocompromised status, including individuals who have undergone organ transplantation, on immunosuppression for an immune mediated disease, or are positive for human immunodeficiency virus (HIV).
Positive test for active hepatitis B or C at Screening. Participants with successfully treated hepatitis B infection which has been resolved for greater than 1 year or successfully treated hepatitis C infection will not be excluded.
Donated more than 250 mL of blood within 30 days of Screening.
Have difficulties with venipuncture/cannulation, including difficulty accessing veins for blood sampling and/or history of coagulopathy or endocarditis.
Current DSM-5 diagnosis of major depressive episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the MINI 7.0.2 or in the judgment of the Investigator. (Note that individuals with depression secondary to schizoaffective disorder are eligible).
Suicidal ideation associated with actual intent and a method or plan in the past 6 months, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; ie, "Yes" answers on items 4 or 5) at Screening or Day -7, or having made a suicide attempt within the last 2 years.
Known or suspected (non -febrile) seizure disorder.
History of neuroleptic malignant syndrome.
Current or history of clinically significant tardive dyskinesia.

Where it is running

CenExel CNS — Garden Grove, California, United States
Atlanta Center for Medical Research — Atlanta, Georgia, United States
Uptown Research Institute — Chicago, Illinois, United States
Hassman Research Institute — Marlton, New Jersey, United States
Community Clinical Research, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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