Back to resultsA Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
Primary Purpose
Analgesia, Acute Pain, Chronic Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
oxycodone hydrochloride
oxycodone hydrochloride
oxycodone hydrochloride
oxycodone hydrochloride
marketed oxycodone hydrochloride
Sponsored by
About this trial
This is an interventional basic science trial for Analgesia focused on measuring bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain
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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Treatment C
Treatment D
Treatment E
Arm Description
Outcomes
Primary Outcome Measures
Maximum Observed Plasma Concentration (Cmax)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Area under the Concentration-Time Curve (AUC)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Secondary Outcome Measures
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
Change from Baseline to each Post-Dose Assessment in Heart Rate
Change from Baseline to each Post-Dose Assessment in Respiratory Rate
Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
Change from Screening to End-of-Study Assessment in Hematology Parameters
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Change from Screening to End-of-Study Assessment in ECG Measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530542
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Acute Pain, Chronic Pain, Narcotic Abuse, Opioid-related Disorders
Keywords
bioavailability, food effect, oxycodone, management of acute and chronic moderate to severe pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Title
Treatment B
Arm Type
Experimental
Arm Title
Treatment C
Arm Type
Experimental
Arm Title
Treatment D
Arm Type
Experimental
Arm Title
Treatment E
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
oxycodone hydrochloride
Intervention Description
oxycodone hydrochloride 5 mg tablet under fasted conditions
Intervention Type
Drug
Intervention Name(s)
oxycodone hydrochloride
Intervention Description
2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
Intervention Type
Drug
Intervention Name(s)
oxycodone hydrochloride
Intervention Description
2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
Intervention Type
Drug
Intervention Name(s)
oxycodone hydrochloride
Intervention Description
2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
Intervention Type
Drug
Intervention Name(s)
marketed oxycodone hydrochloride
Intervention Description
1 x oxycodone hydrochloride 15 mg tablet under fed conditions
Primary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Screening up to approximately 3 months
Title
Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time Frame
Screening up to approximately 3 months
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
Change from Screening to End-of-Study Assessment in Hematology Parameters
Time Frame
Screening up to approximately 3 months
Title
Change from Screening to End-of-Study Assessment in Chemistry Parameters
Time Frame
Screening up to approximately 3 months
Title
Change from Screening to End-of-Study Assessment in Urinalysis Parameters
Time Frame
Screening up to approximately 3 months
Title
Change from Screening to End-of-Study Assessment in ECG Measurements
Time Frame
Screening up to approximately 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22717418
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=K234-10-1001&StudyName=A%20Clinical%20Study%20To%20Characterize%20The%20Pharmacokinetics%20And%20The%20Effects%20Of%20Food%20On%20Oxycodone%20In%20Healthy%20Volunteers%0A
Description
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A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers
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