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Completed

NCT Number: NCT02165930

Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers

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Key information

Conditions

Healthy

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Overland Park, Kansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • History of moderate alcohol consumption
  • Total body weight exceeding 64 kg

Exclusion criteria

  • Evidence or history of clinically significant disease.
  • Positive urine drug test
  • History of alcoholism or heavy alcohol consumption

Treatment and study plan

Oxycodone

Drug

One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions

Naltrexone

Drug

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).

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

    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

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

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

  2. Concentration at time 24 hours (C24)

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

  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

  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

    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, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2014
Registry last updated
Apr 4, 2016

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

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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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