Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Di… (NCT05321602) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
United States89 participantsStarted 2021-09-08
Plain-language summary
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Capable of giving informed consent and complying with study procedures.
✓. Have an identified support person (e.g., family member, case worker, social worker) considered reliable by the Investigator to help ensure compliance with study visits and to alert staff of any issues of concern.
✓. Have a stable place of residence for the 3 months prior to screening and throughout the study.
✓. Male or female ≥18 to ≤65 years of age who meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening.
✓. Have been on a stable dose of oral antipsychotic medication(s) other than risperidone, paliperidone, clozapine, ziprasidone, or thioridazine for at least 4 weeks prior to screening.
✓. Be clinically stable based on clinical assessments and a Positive and Negative Syndrome Scale (PANSS) total score ≤75 as well as a PANSS HATE (hostility, anxiety, tension and excitement) subtotal score \<16 at screening.
✓. Clinical Global Impression-Severity (CGI-S) score of 1 to 4, inclusive.
✓. For patients with schizoaffective disorder only: Young Mania Rating Scale (YMRS) ≤12 and Hamilton Rating Scale for Depression, 17-item version (HAM-D) ≤12.
Exclusion criteria
✕. Primary and active DSM-V Axis I diagnosis other than schizophrenia or Schizoaffective disorder.
✕
What they're measuring
1
Pharmacokinetic (PK) profiles of paliperidone in LY03010
. Patients who meet DSM-V criteria for substance abuse (moderate or severe), or test positive for a drug of abuse or alcohol at screening or baseline with the exception of test positive for barbiturate or benzodiazepine which can be accounted for by documented prescriptions from a treating physician as a part of the treatment for the patient's underlying medical conditions.
✕. Patients who received any of the following treatment(s):
✕. Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test will be completed during the screening period, approximately14 days but no less than 9 days prior to dosing, for patients without documented evidence \[medical record or written statement from a licensed medical practitioner who has treated the patient\] of tolerating risperidone or paliperidone, and patients who show an allergic reaction to this test will be excluded from the study).
✕. Patients who pose a significant risk of a suicide attempt based on history or the Investigator's judgment; answer "yes" to Suicidal Ideation items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) for current or past 6 months on the "Baseline/Screening version" at screening; have had suicidal behavior in the last 6 months as measured by the C-SSRS at screening; or are at imminent risk of suicide or violent behavior based on the Investigator's clinical assessment or the C-SSRS assessment of lifetime suicidal ideation or behavior at screening.
✕. Any one or more of the following 3 conditions: (i) clinically significant liver dysfunction, (ii) hepatitis B surface antigen (HBsAg) positive, hepatitis C (HCV) positive, or (iii) a serum alanine transaminase (ALT) or aspartate transaminase (AST) \> 2 x upper limit of normal (ULN) range; or a total bilirubin \> 1.5 x ULN (if the ALT or AST levels are between 2x and 3x ULN in the first screening test and the elevation may be caused by non-specific reasons in the judgment of the Investigator, a second test can be performed after one week. If the repeated ALT or AST levels are still \>2 x ULN, the patient must be excluded from the study. Patients who are HCV antibody reactive but confirmed HCV RNA not detected may be enrolled, if this condition has been previously considered stable without treatment or after the completion of appropriate treatment, and liver function is normal.
✕. History of symptomatic orthostatic hypotension or with a decrease of ≥ 20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from supine to standing position after having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in a supine position at screening or prior to randomization.
✕. Uncontrolled diabetes or hemoglobin A1c (HbAlc) level ≥7% at screening.