Relative Bioavailability of LY03010 Compared to Listed Drug
Condition: Schizophrenia; Psychotic Disorders; Mood Disorders; Schizophrenia Spectrum; Mental Disorders; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo
      screening evaluations to determine eligibility within 28 days prior to study drug
      administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1
      of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before
      dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will
      stay at site till Day 2 after PK collection. All subjects will return to the clinical sites
      at designated study days for dosing, PK sample collections and assigned clinical activities.

      All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg
      LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing
      of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects
      randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM
      injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in
      the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the
      gluteal muscle with the last dose on Day 148.

      End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last
      dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last
      dosing. At EOS visit, subjects will complete the study after a series of assigned clinical
      assessments. A 30-day follow up call will be conducted by the clinical research staff to
      ensure participant's well-being.
    

Detailed description: 
      This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo
      screening evaluations to determine eligibility within 28 days prior to study drug
      administration. Approximately 280 eligible subjects will be randomized in a 1:1 ratio into 1
      of 2 treatment groups. Subjects will be admitted to the clinical facilities the day before
      dosing (Day 0), and will be randomized and receive the first dosing on Day 1. Subjects will
      stay at site till Day 2 after PK collection. All subjects will return to the clinical sites
      at designated study days for dosing, PK sample collections and assigned clinical activities.

      All subjects randomized to LY03010 treatment group will receive the first dose of 351 mg
      LY03010 by IM injection on Day 1 in the deltoid muscle, followed by five (5) monthly dosing
      of 156 mg LY03010 in the gluteal muscle with the last dose on Day 141. All subjects
      randomized to SUSTENNA treatment group will receive the first dose of 234 mg SUSTENNA by IM
      injection on Day 1 in the deltoid muscle, and a second IM dose of 156 mg SUSTENNA on Day 8 in
      the deltoid muscle, followed by five (5) monthly IM dosing of 156 mg of SUSTENNA in the
      gluteal muscle with the last dose on Day 148.

      On the day before the last dosing day visit (Day 140 for LY03010 treatment group and Day 147
      for SUSTENNA treatment group), subjects will come to the clinical facility and stay at sites
      for 8 days for PK collection and other assigned activities. The schedules of assessments for
      each treatment group are listed in Table 2 and Table 3.

      End of Study (EOS) visit for LY03010 treatment group will be on Day 169, 28 days after last
      dosing day; End of Study for SUSTENNA treatment group will be on Day 176, 28 days after last
      dosing. At EOS visit, subjects will complete the study after a series of assigned clinical
      assessments. A 30-day follow up call will be conducted by the clinical research staff to
      ensure participant's well-being.
    

Intervention name(s): LY03010; paliperidone palmitate; INVEGA SUSTENNA
Intervention type(s): Drug; Drug
Intervention description(s): LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.; INVEGA SUSTENNA (234 mg, 156 mg) is manufactured by Janssen Pharmaceuticals, Inc and is commercially available.
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone Palmitate; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Dopamine Agents