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Pharmacokinetics Study of ALO-02 and OxyContin

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NCT01557257

Last updated on November 21, 2019
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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Management of Moderate to Severe Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence or history of clinically significant diseases.

NCT01557257
Pfizer
Completed
Pharmacokinetics Study of ALO-02 and OxyContin

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Descriptive Information
Brief Title  ICMJE Pharmacokinetics Study of ALO-02 and OxyContin
Official Title  ICMJE An Open-label, Single-dose and Multiple-dose, Randomized, Crossover Study to Evaluate Pharmacokinetics, Safety and Tolerability After Administration of ALO-02 40 Mg Twice Daily Compared to ALO-02 80 Mg Once Daily and to Oxycontin 40 Mg Twice Daily in Healthy Volunteers
Brief SummaryTo characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers
Detailed DescriptionNot 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 Management of Moderate to Severe Pain
Intervention  ICMJE
  • Drug: ALO-02
    Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily)
  • Drug: Naltrexone block
    Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
  • Drug: ALO-02
    Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily)
  • Drug: Naltrexone block
    Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose and 11.5 hours after the AM dosing on Days 2-5, (3) 23.5 hours after Day 5 dosing.
  • Drug: OxyContin
    Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily)
Study Arms  ICMJE
  • Experimental: 40 mg ALO-02 capsule
    Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block
    Interventions:
    • Drug: ALO-02
    • Drug: Naltrexone block
  • Experimental: 80 mg ALO-02 capsule
    Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block
    Interventions:
    • Drug: ALO-02
    • Drug: Naltrexone block
  • Experimental: 40 mg OxyContin tablet
    Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
    Interventions:
    • Drug: OxyContin
    • Drug: Naltrexone block
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: June 26, 2012)		13
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2012)		12
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateMay 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 NCT01557257
Other Study ID Numbers  ICMJE B4531006
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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