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A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01552863
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : March 2012
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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
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 E, 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 F, 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 G, 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 5 mg PF-00345439 Formulation TBD, 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 H, single dose


Outcome Measures

Primary Outcome Measures :
  1. Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]
  2. Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]
  3. Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]
  4. Plasma Concentration 24 Hours Post-Dose (C24) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose. ]
  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]
  6. Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552863


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pain Therapeutics
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT01552863     History of Changes
Other Study ID Numbers: B4501018
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Keywords provided by Pain Therapeutics:
pharmacokinetics
bioavailability
oxycodone.

Additional relevant MeSH terms:
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents