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Pharmacokinetics Study of ALO-02 and OxyContin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01557257
First received: March 15, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

To 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


Condition Intervention Phase
Management of Moderate to Severe Pain
 Drug: ALO-02
Drug: Naltrexone block
Drug: OxyContin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Area under the plasma concentration versus time curve within a dosing interval of τ at steady state (AUCτ) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Maximum plasma concentration at steady state on Day 5 (Cmax,ss) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Minimum plasma concentration at steady state on Day 5 (Cmin,ss) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Average plasma concentration at steady state on Day 5 (Cave,ss) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration on Day 5 (Tmax) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Plasma Decay Half-Life (t1/2) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Accumulation ratio based on Area Under Curve (AUC) (Rac) of oxycodone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Single-dose administration: Dose normalized Maximum Observed Plasma Concentration (Cmax(dn)) of oxycodone, noroxycodone, and oxymorphone. [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Dose-normalized Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24(dn)) of oxycodone, noroxycodone, and oxymorphone. [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone. [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone. [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone. [ Time Frame: 0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Accumulation ratio (Rac) of oxycodone, as data permit [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone, as data permit [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Area under the plasma concentration versus time curve within a dosing interval of τ (AUCτ) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Maximum plasma concentration at steady state (Cmax,ss) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Minimum plasma concentration at steady state (Cmin,ss) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Average plasma concentration at steady state (Cave,ss) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Plasma Decay Half-Life (t1/2) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Rac of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]
  • Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone, as data permit. [ Time Frame: 96,96.5,97,98,100,102,104,108,108.5,109,110,112,114,116,120,132,144,168 hours post Day 1 dosing ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg ALO-02 capsule
Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block
 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
Experimental: 80 mg ALO-02 capsule
Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block
 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.
Experimental: 40 mg OxyContin tablet
Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block
 Drug: OxyContin
Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, 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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557257

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01557257     History of Changes
Other Study ID Numbers: B4531006
Study First Received: March 15, 2012
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
single- and multiple-dose pharmacokinetics
ALO-02
OxyContin

Additional relevant MeSH terms:
Naltrexone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013