A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers
- Registration Number
- NCT01552863
- Lead Sponsor
- Pain Therapeutics
- Brief Summary
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.
- Detailed Description
This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- Healthy male and/or female subjects between 18 and 55 years of age (inclusive).
- Evidence or history of clinically significant disease.
- History of obstructive sleep apnea.
- Positive urine drug test.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment C Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment B Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment A Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment D Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment F Oxycodone Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). Treatment E Oxycodone Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
- Primary Outcome Measures
Name Time Method Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. Maximum Observed Plasma Concentration (Cmax) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
- Secondary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. Plasma Concentration 24 Hours Post-Dose (C24) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose. Time to Reach Maximum Observed Plasma Concentration (Tmax) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. Plasma Decay Half-Life (t1/2) 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States