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):
Pfizer
ClinicalTrials.gov Identifier:
NCT01552863
First received: March 9, 2012
Last updated: October 8, 2012
Last verified: October 2012

March 9, 2012
October 8, 2012
March 2012
September 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01552863 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Management of Moderate to Severe Pain
  • 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 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).
    Intervention: Drug: Oxycodone
  • 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).
    Intervention: Drug: Oxycodone
  • 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).
    Intervention: Drug: Oxycodone
  • 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).
    Intervention: Drug: Oxycodone
  • 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).
    Intervention: Drug: Oxycodone
  • 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).
    Intervention: Drug: Oxycodone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01552863
B4501018
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP