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Trial record 85 of 756 for:    Area Under Curve AND Bioavailability

Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165930
Recruitment Status : Completed
First Posted : June 18, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
PainT ( Pain Therapeutics )

Tracking Information
First Submitted Date  ICMJE June 10, 2014
First Posted Date  ICMJE June 18, 2014
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • 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).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2014)
  • 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)
  • Concentration at time 24 hours (C24) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  • 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 ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Oxycodone
    One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
  • Drug: Naltrexone
    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
    One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
  • Drug: Naltrexone
    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).
Study Arms  ICMJE
  • Experimental: Treatment A
    Interventions:
    • Drug: Oxycodone
    • Drug: Naltrexone
  • Experimental: Treatment B
    Interventions:
    • Drug: Oxycodone
    • Drug: Naltrexone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2014)
17
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2014)
14
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02165930
Other Study ID Numbers  ICMJE B4501037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PainT ( Pain Therapeutics )
Study Sponsor  ICMJE Pain Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account PainT
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP