A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT01530542
• Recruitment Status: Completed
• First Posted: February 10, 2012
• Last Update Posted: February 24, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 18, 2012
• First Posted Date: February 10, 2012
• Last Update Posted Date: February 24, 2012
• Study Start Date: July 2010
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2012)

• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ]
• Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ]
• Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ]
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ]
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, and 24 hours post-dose. ]

• Original Primary Outcome Measures (submitted: February 7, 2012): Pharmacokinetics of oxycodone after single-dose administration (maximum observed plasma concentration [Cmax], time-to-Cmax [Tmax], half-life, elimination rate constant, area under the plasma concentration-time curve [AUClast, AUCinf]) [ Time Frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24 ]
• Change History: Complete list of historical versions of study NCT01530542 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: February 22, 2012)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]
• Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]
• Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ]
• Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ]
• Change from Baseline to each Post-Dose Assessment in Heart Rate [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ]
• Change from Baseline to each Post-Dose Assessment in Respiratory Rate [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ]
• Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %) [ Time Frame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose. ]
• Change from Screening to End-of-Study Assessment in Hematology Parameters [ Time Frame: Screening up to approximately 3 months ]
• Change from Screening to End-of-Study Assessment in Chemistry Parameters [ Time Frame: Screening up to approximately 3 months ]
• Change from Screening to End-of-Study Assessment in Urinalysis Parameters [ Time Frame: Screening up to approximately 3 months ]
• Change from Screening to End-of-Study Assessment in ECG Measurements [ Time Frame: Screening up to approximately 3 months ]

Original Secondary Outcome Measures (submitted: February 7, 2012)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]
• Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Screening up to approximately 3 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
• Official Title: Open-Label, Single-Dose, Randomized, 5-Period, 5-Way Crossover Study To Evaluate The Dose Proportionality And The Effects Of Food On The Bioavailability Of Acurox Tablets In Healthy Volunteers
• Brief Summary: This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 5-dosing period study to characterize the pharmacokinetics (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of oxycodone. The study will take place over approximately two and a half months and will consist of three phases: a screening visit to determine eligibility for the study, a 5-dosing period treatment phase, and an end-of-study visit.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Analgesia
• Acute Pain
• Chronic Pain
• Narcotic Abuse
• Opioid-related Disorders

Intervention

• Drug: oxycodone hydrochloride
  oxycodone hydrochloride 5 mg tablet under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
• Drug: oxycodone hydrochloride
  2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
• Drug: marketed oxycodone hydrochloride
  1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Study Arms

• Experimental: Treatment A
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment B
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment C
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment D
  Intervention: Drug: oxycodone hydrochloride
• Experimental: Treatment E
  Intervention: Drug: marketed oxycodone hydrochloride

• Publications *: Bass A, Stark JG, Pixton GC, Sommerville KW, Zamora CA, Leibowitz M, Rolleri R. Dose proportionality and the effects of food on bioavailability of an immediate-release oxycodone hydrochloride tablet designed to discourage tampering and its relative bioavailability compared with a marketed oxycodone tablet under fed conditions: a single-dose, randomized, open-label, 5-way crossover study in healthy volunteers. Clin Ther. 2012 Jul;34(7):1601-12. doi: 10.1016/j.clinthera.2012.05.009. Epub 2012 Jun 19.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2012): 35
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01530542
• Other Study ID Numbers: K234-10-1001; B4501006
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2012