A 5-Way Crossover Study of ER Levorphanol Versus IR Levorphanol

• Research type

  Research Study

• Full title

  An Open-Label, Randomized, Single-Dose, Five-Way Crossover Study of the Oral Bioavailability of 5, 10, and 20 mg Doses of Extended Release (ER), Abuse Resistant Levorphanol Under Fasted and Fed Conditions Vs. Immediate Release (IR) Levorphanol Under Fasted Conditions When Administered Under Naltrexone Block to Healthy Adult Volunteers.

• IRAS ID

  119840

• Contact name

  Ronnie Beboso

• Sponsor organisation

  Relmada Therapeutics Inc

• Eudract number

  2012-005382-12

• Research summary

  This is a single centre, open-label, randomized, five-way crossover study. Thirty healthy volunteers aged 18 to 50 will be enrolled and assigned to one of five treatments during each of the five study periods. The study will compare extended release Levorphanol to immediate release Levorphanol (currently marketed in US). For fed treatment (treatment D); following an overnight fast of at least 10 hours those assigned to treatment D will eat their meal (a high fat breakfast) 30 minutes prior to administration of the Levorphanol dose. For fasting treatments, volunteers will begin fasting on the evening of Day -1 (a minimum of 10 hours pre-dose) and continue until 4 hours post dose on Day 1. They must abstain from eating for a minimum of 10 hours prior and 4 hours after each study medication dose. Each study period will be approximately 2 and a half days long. Each person will come into the study unit early on Day -1 for a blood draw prior to check-in of each study period and receive naltrexone 12 hours prior to administration of Levorphanol on Day 1. They will remain in the unit until Day 3 (approximately 48 hours post dose). They will receive naltrexone at -13hrs, -1hr, 11hrs, 23 hrs and 47 hrs post levorphanol dosing. A washout period of 7 to 14 days will separate each study period. The expected duration of each volunteer's participation from the time of initial screening to the completion of the study will be approximately 8 weeks.

• REC name

  HSC REC A

• REC reference

  12/NI/0189

• Date of REC Opinion

  10 Jan 2013

• REC opinion

  Further Information Favourable Opinion