A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone; Drug: Oxycodone

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and/or female subjects between 18 and 55 years of age (inclusive).

Exclusion Criteria:

• Evidence or history of clinically significant disease.
• History of obstructive sleep apnea.
• Positive urine drug test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose
Experimental: Treatment B; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose
Experimental: Treatment C; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose
Experimental: Treatment D; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose
Experimental: Treatment E; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose
Experimental: Treatment F; 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).	Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation A, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation E, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation F, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation G, single dose; Drug: Oxycodone; One capsule of 5 mg PF-00345439 Formulation TBD, single dose; Drug: Oxycodone; One capsule of 40 mg PF-00345439 Formulation H, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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 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.
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.

Collaborators and Investigators

• Sponsor: Pain Therapeutics

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 31, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: pharmacokinetics; bioavailability; oxycodone.
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: B4501018