NCT01552863

Brief Summary

This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1 pain

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

March 9, 2012

Last Update Submit

August 28, 2015

Conditions

Pain

Keywords

pharmacokineticsbioavailabilityoxycodone.

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  • Maximum Observed Plasma Concentration (Cmax)

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

Secondary Outcomes (6)

  • Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  • Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  • Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  • Plasma Concentration 24 Hours Post-Dose (C24)

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose.

  • +1 more secondary outcomes

Study Arms (6)

Treatment A

EXPERIMENTAL

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

Treatment B

EXPERIMENTAL

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

Treatment C

EXPERIMENTAL

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

Treatment D

EXPERIMENTAL

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

Treatment E

EXPERIMENTAL

Single dose of 5 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

Treatment F

EXPERIMENTAL

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

Interventions

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation A, single dose

Treatment A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic 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

March 9, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

US(1)