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Completed

NCT Number: NCT01924676

Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Baltimore, Maryland, 21225, United States

About this study

This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers.

Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Evidence or history of clinically significant disease
  • Positive urine drug test

Treatment and study plan

Oxycodone

Drug

One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  2. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

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

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

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

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  4. Plasma Decay Half-Life (t1/2)

    Time frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pain Therapeutics

Industry

Registry information

Official study title

An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2013
Registry last updated
Aug 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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