Trial record 1 of 1 for:    NCT01552863
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A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pain Therapeutics
ClinicalTrials.gov Identifier:
NCT01552863
First received: March 9, 2012
Last updated: August 28, 2015
Last verified: August 2015
  Purpose

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 Intervention Phase
Pain
Drug: Oxycodone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pain Therapeutics:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pain Therapeutics
ClinicalTrials.gov Identifier: NCT01552863     History of Changes
Other Study ID Numbers: B4501018
Study First Received: March 9, 2012
Last Updated: August 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pain Therapeutics:
pharmacokinetics
bioavailability
oxycodone.

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

ClinicalTrials.gov processed this record on September 03, 2015