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Trial record 79 of 667 for:    OXYCODONE

Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

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ClinicalTrials.gov Identifier: NCT01456507
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 13, 2011
First Posted Date  ICMJE October 20, 2011
Last Update Posted Date September 28, 2018
Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
  • Area Under the Curve (AUC) to time infinity (inf) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  • Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  • Maximum Plasma Concentration (Cmax) of oxycodone [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
  • Area Under the Curve (AUC) to time infinity (inf) of oxycodone [ Time Frame: over 48 hours ]
  • Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone [ Time Frame: over 48 hours ]
  • Maximum Plasma Concentration (Cmax) of oxycodone [ Time Frame: over 48 hours ]
Change History Complete list of historical versions of study NCT01456507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
  • C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. [ Time Frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose ]
  • AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit [ Time Frame: predose, 1,2,4,8,12,24,48,120 hours post-dose ]
  • Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. [ Time Frame: over 120 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2011)
  • C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. [ Time Frame: over 48 hours ]
  • AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit [ Time Frame: over 120 hours ]
  • Adverse events, vital signs, pulse oximetry, suicidality and safety laboratory parameters. [ Time Frame: over 120 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone
Official Title  ICMJE An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg
Brief Summary The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.
Detailed Description Bioavailability
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ALO-02 (Oxycodone Naltrexone)
    single dose of ALO-02 capsule under fasting condition
  • Drug: ALO-02 (Oxycodone Naltrexone)
    single dose of ALO-02 capsule under fed condition
  • Drug: ALO-02 (Oxycodone Naltrexone)
    ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
Study Arms  ICMJE
  • Experimental: A
    1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
    Intervention: Drug: ALO-02 (Oxycodone Naltrexone)
  • Experimental: B
    1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
    Intervention: Drug: ALO-02 (Oxycodone Naltrexone)
  • Experimental: C
    1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions.
    Intervention: Drug: ALO-02 (Oxycodone 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: October 18, 2011)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive

Exclusion Criteria:

  • Evidence or history of clinically significant diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT01456507
Other Study ID Numbers  ICMJE B4531003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018

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