Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005 (NCT05779241) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Pharmacokinetics (PK) and Safety/Tolerability of Long-Acting Oral LYN-005
United States83 participantsStarted 2023-04-13
Plain-language summary
Lyndra Therapeutics, Inc. is developing LYN-005, a long-acting oral (LAO) capsule (LYNXâ„¢ 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.
Who can participate
Age range18 Years – 64 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Minimum Observed Concentration (Cmin) at Week 1
Timeframe: up to Day 36
2
Minimum Observed Concentration (Cmin) at Week 5
Timeframe: up to Day 36
3
Maximal Observed Concentration (Cmax) at Week 5
Timeframe: up to Day 36
4
Average Concentration Over the Dosing Interval (Cavg) at Week 5
✕. 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.