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Pharmacokinetics And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pain Therapeutics
ClinicalTrials.gov Identifier:
NCT01717027
First received: October 26, 2012
Last updated: August 28, 2015
Last verified: August 2015
  Purpose
To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Condition Intervention Phase
Healthy
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 And Relative Bioavailability Of Oxycodone Following Oral Administration Of 40 Mg Doses Of PF 00345439 Taken Whole Under Fed Conditions And After Chewing Under Fasted 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 (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 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, 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]
  • Concentration at time 24 hours (C24) of oxycodone, as data permit. [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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, taken whole and under fed conditions
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 J, single dose, taken whole and under fed conditions
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 K, single dose, taken whole and under fed conditions
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 J or K, single dose, chewed and under fasted conditions

Detailed Description:

This study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulations J and K compared with the reference PF-00345439 Formulation A, all taken whole and under fed conditions in healthy volunteers.

In addition, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone followingoral administration of single 40 mg doses of PF-00345439 Formulation J or K (to beselected based on Periods 1-3) after chewing under fasted conditions compared to that taken whole in the fed state in healthy volunteers, and assess the single-dose safety and tolerability of oxycodone inPF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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.
  • 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: NCT01717027

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: NCT01717027     History of Changes
Other Study ID Numbers: B4501034 
Study First Received: October 26, 2012
Last Updated: August 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pain Therapeutics:
pharmacokinetics
bioavailability
oxycodone
management of moderate to severe pain

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

ClinicalTrials.gov processed this record on December 02, 2016