A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult
      subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose
      of 28 mg LY03003 and 1 week of 4 mg q24h NEUPRO® patch. Subjects will be randomized 1:1 to 1
      of the 2 treatment sequences.
    

Detailed description: 
      Sequence 1

      Period 1:

      Subjects will check into the clinical research unit (CRU) on Day 0. On Day 1, subjects will
      receive the first 4 mg NEUPRO® patch in the morning. On Days 2 to 7, subjects will receive a
      4- mg NEUPRO® patch every 24 hours (+/- 30 minutes) on one of the 7 designated patch
      application sites (see Section 12.2). On Day 1, serial PK samples will be collected within 30
      minutes prior to patch application and 2, 4, 8, 12, 16, 20 hours post patch application. On
      Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch (<30 minutes pre-patch)
      application only. On Day 7, the subjects will receive the NEUPRO® patch and serial PK samples
      will be collected pre-patch (<30 mins pre-patch) application and at 2, 4, 6, 8, 12, 16, 20,
      24, 26, 28, 30, 33, 36, and 48 hours post-patch application Subject will stay at CRU till Day
      14 to complete the End of Treatment ( EOT) procedures and prepare for the LY03003 treatment
      in Period 2 on the next day.

      Period 2:

      On Day 1 in the morning, subjects will receive a single-dose IM injection of 28 mg LY03003.
      Serial PK samples will be collected within 30 minutes pre-dosing and at 0.5, 1, 6, and 12
      hours post dosing on Day 1. On Days 2 to Day 8, Day 10, Day 12, Day 15, Day 17, and Day 22,
      one single post-dose PK sample will be collected at the following corresponding hours: 24,
      48, 72, 96, 120, 144, 168, 216, 264, 336, 384, and 504 hours post dosing. Subjects will stay
      at CRU till Day 22 to have PK collected and EOT activities completed. Subjects will be
      discharged on the same day. A 7-day safety follow-up period will be followed with a call on
      Day 29.

      Sequence 2 Period 1 Subjects will check into the CRU on Day 0. In the morning of Day 1,
      subjects will receive a single-dose IM injection of 28 mg LY03003. Serial PK samples will be
      collected within 30 minutes pre-dosing and at 0.5, 1, 6 and 12 hours post dosing on Day 1. On
      Days 2 to Day 8, Day 10, Day 12, and Day 15, Day 17, and Day 22, one single postdose PK
      sample will be collected at the following corresponding hours: 24, 48, 72, 96, 120, 144, 168,
      216, 264, 336, 384, and 504 hours post dosing. On Day 22, Subjects will have PK samples
      collected and EOT activities completed. Subjects will stay at the CRU until Day 29 and
      complete a 7-day washout period and to prepare for NEUPRO® patch treatment in Period 2 on the
      next day.

      Period 2 On Day 1, subjects will receive the first 4 mg NEUPRO® patch in the morning. On Days
      2 to 7, subjects will receive a 4- mg NEUPRO® patch every 24 hours (+/- 30 mins) on one of
      the 7 designated patch application sites (see Section 12.2). On Day 1, serial PK samples will
      be collected within 30 minutes prior to patch application and 2,4, 8, 12, 16 and 20 hours
      post patch application. On Days 2, 3, 4, 5 and 6, one PK sample will be collected pre-patch
      (<30 minutes pre-patch) application only. On Day 7, the subjects will receive the NEUPRO®
      patch and serial PK samples will be collected pre-patch (<30 minutes pre-patch) application
      and at 2, 4, 6, 8, 12, 16, 20, 24, 26, 28, 30, 33, 36, and 48 hours post-patch application.
      Subjects will stay at CRU and continue the safety follow-up period until Day14. On Day 14,
      subjects will complete EOT activities, followed by being discharged from the study on the
      same day.
    

Intervention name(s): LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection); Neupro 4 mg / 24 Hr. Transdermal Patch
Intervention type(s): Drug; Other
Intervention description(s): LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection); Neupro 4 mg /24 Hr. Transdermal Patch
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a randomized, open-label, 2-sequence, 2-treatment cross-over study to evaluate the rotigotine PK profiles after a single dose of 28 mg LY03003 IM injection and 7 days of 4 mg NEUPRO® patch q24h in healthy subjects.
Subjects will be screened according to the inclusion and exclusion criteria (Days -28 to -1) prior to randomization. Each subject will be randomized 1:1 to 1 of the 2 treatment sequences and will participate in 2 treatment periods.
Masking: None (Open Label)
Primary purpose: Basic Science