NCT01552850

Brief Summary

To estimate the pharmacokinetics and relative bioavailability of oxycodone after administration of 40 mg doses of four PF-00345439 formulations and oxycodone in solution

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 pain

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_1 pain

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

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 31, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

March 9, 2012

Last Update Submit

August 28, 2015

Conditions

Pain

Keywords

pharmacokineticsrelative bioavailabilityoxycodone

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 (5)

  • 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

  • Adverse events, vital signs and laboratory parameters.

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

Study Arms (5)

Oxycodone Formulation A Capsule

EXPERIMENTAL

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Drug: Oxycodone

Oxycodone Formulation B Capsule

EXPERIMENTAL

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Drug: Oxycodone

Oxycodone Formulation C Capsule

EXPERIMENTAL

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Drug: Oxycodone

Oxycodone Formulation D Capsule

EXPERIMENTAL

single dose of 40 mg PF-00345439 capsule under 50 mg naltrexone block

Drug: Oxycodone

Oxycodone Oral Solution

EXPERIMENTAL

40 mg oxycodone oral solution (5 mg/5 ml) under 50 mg naltrexone block

Drug: Oxycodone

Interventions

OxycodoneDRUG

1X40 mg PF-00345439 formulation A capsule with water and under fed condition

Oxycodone Formulation A Capsule

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive

You may not qualify if:

  • Evidence or history of clinically significant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

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

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

August 31, 2015

Record last verified: 2015-08

Locations

SG(1)