Clinical trial NCT01530542: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Analgesia
Acute Pain
Chronic Pain
Narcotic Abuse
Opioid-related Disorders
Keywords: bioavailability
food effect
oxycodone
management of acute and chronic moderate to severe pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 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.
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 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.
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 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.
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: 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 outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Screening up to approximately 3 months
measure: Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Screening up to approximately 3 months
measure: Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
measure: Change from Baseline in Systolic Blood Pressure at each Post-Dose Assessment
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
measure: Change from Baseline to each Post-Dose Assessment in Heart Rate
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
measure: Change from Baseline to each Post-Dose Assessment in Respiratory Rate
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
measure: Change from Baseline to each Post-Dose Assessment in Pulse Oximetry (SpO2, %)
timeFrame: 0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.
measure: Change from Screening to End-of-Study Assessment in Hematology Parameters
timeFrame: Screening up to approximately 3 months
measure: Change from Screening to End-of-Study Assessment in Chemistry Parameters
timeFrame: Screening up to approximately 3 months
measure: Change from Screening to End-of-Study Assessment in Urinalysis Parameters
timeFrame: Screening up to approximately 3 months
measure: Change from Screening to End-of-Study Assessment in ECG Measurements
timeFrame: Screening up to approximately 3 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.