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

NCT01530542 | Completed Phase 1

• 2 other identifiers: K234-10-1001B4501006
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Maximum Observed Plasma Concentration (Cmax)

  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)

  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)

  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)

  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 - ∞)]

  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 (11)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Screening up to approximately 3 months

• Percentage of participants with treatment-emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Screening up to approximately 3 months

• Change from Baseline in Diastolic Blood Pressure at each Post-Dose Assessment

  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

  0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.

• Change from Baseline to each Post-Dose Assessment in Heart Rate

  0, 0.5, 1, 2, 4, 8, 12, and 24 hours post-dose.

Study Arms (5)

Treatment A

EXPERIMENTAL

Drug: oxycodone hydrochloride

Treatment B

EXPERIMENTAL

Drug: oxycodone hydrochloride

Treatment C

EXPERIMENTAL

Drug: oxycodone hydrochloride

Treatment D

EXPERIMENTAL

Drug: oxycodone hydrochloride

Treatment E

EXPERIMENTAL

Drug: marketed oxycodone hydrochloride

Interventions

oxycodone hydrochloride DRUG

oxycodone hydrochloride 5 mg tablet under fasted conditions

Treatment A

marketed oxycodone hydrochloride DRUG

1 x oxycodone hydrochloride 15 mg tablet under fed conditions

Treatment E

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects between 18 and 55 years of age (inclusive)

You may not qualify if:

• Evidence or history of clinically significant disease;
• History of obstructive sleep apnea;
• Positive urine drug test.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

• 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.

  PMID: 22717418 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Agnosia; Acute Pain; Chronic Pain; Narcotic-Related Disorders; Opioid-Related Disorders

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: February 10, 2012
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)