NCT01717027

Brief Summary

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of PF-00345439 formulations taken whole under fed conditions and after chewing under fasted conditions in healthy volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

October 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

October 26, 2012

Last Update Submit

August 28, 2015

Conditions

Healthy

Keywords

pharmacokineticsbioavailabilityoxycodonemanagement of moderate to severe pain

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) (if data permit, otherwise Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUClast]) of oxycodone.

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

  • Maximum Observed Plasma Concentration (Cmax)

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

Secondary Outcomes (4)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of oxycodone, as data permit

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

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone, as data permit.

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

  • Plasma Decay Half-Life of oxycodone, as data permit.

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

  • Concentration at time 24 hours (C24) of oxycodone, as data permit.

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

Study Arms (4)

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

Interventions

OxycodoneDRUG

One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions

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.
  • 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

Interventions

Oxycodone

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

October 26, 2012

First Posted

October 30, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

US(1)