Clinical Trial 45969

Garden Grove, CA 92845


Summary:

This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood of Schizophrenia Patients



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 according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) for at least 1 year before screening;
  • Be 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 ≤70 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;
  • Body mass index (BMI) ≥17.0 and ≤37 kg/m2; body weight ≥50 kg;
  • Creatinine level within the normal range;
  • All female patients (childbearing potential and non-childbearing potential) must have a negative pregnancy test result at both screening and baseline. Female patients must meet 1 of the following 3 conditions: (i) postmenopausal for at least 12 months without an alternative medical cause, (ii) surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal occlusion) based on patient report, or (iii) if of childbearing potential (WOCBP), practicing or agree to practice a highly effective contraception method of birth control. Highly effective methods of birth control include an intrauterine device (IUD), intrauterine hormone-releasing system (IUS), and contraceptives (oral, skin patches, or implanted or injectable products) using combined or progestogen-only hormonal contraception associated with inhibition of ovulation. A vasectomized male partner is an acceptable birth control method if the vasectomized partner is the sole sexual partner of the female patient and the vasectomized partner has received medical confirmation of surgical success. Highly effective methods of birth control must be used for at least 14 days prior to study drug dosing, throughout the study, and for another 80 days after the end-of-treatment (EOT) visit (or at least 200 days after the dose, whichever is longer) to minimize the risk of pregnancy;
  • Sexually active fertile male patients must be willing to use acceptable contraception methods (such as double barrier methods of a combination of male condom with either cap, diaphragm or sponge with spermicide) from study drug dosing, throughout the study, and for another 80 days after the EOT visit (or at least 200 days after the dose, whichever is longer) if their partners are women of childbearing potential.


Qualified Participants May Receive:

Monetary compensation for participating.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.