Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-29 @ 3:19 PM
Study NCT ID:
NCT01557257
Status:
COMPLETED
Last Update Posted:
2012-06-28
First Post:
2012-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Study of ALO-02 and OxyContin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608978', 'term': 'oxycodone naltrexone combination'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-26', 'studyFirstSubmitDate': '2012-03-15', 'studyFirstSubmitQcDate': '2012-03-15', 'lastUpdatePostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of oxycodone', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Multiple-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': '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.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Maximum plasma concentration at steady state on Day 5 (Cmax,ss) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Minimum plasma concentration at steady state on Day 5 (Cmin,ss) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Average plasma concentration at steady state on Day 5 (Cave,ss) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration on Day 5 (Tmax) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Plasma Decay Half-Life (t1/2) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of oxycodone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Accumulation ratio based on Area Under Curve (AUC) (Rac) of oxycodone, as data permit.', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'Single-dose administration: Dose normalized Maximum Observed Plasma Concentration (Cmax(dn)) of oxycodone, noroxycodone, and oxymorphone.', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': '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.', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Single-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone.', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Single-dose administration: Area under the plasma concentration versus time curve from time zero to 24 hours (AUC24) of noroxycodone and oxymorphone.', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Single-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone.', 'timeFrame': '0, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post Day 1 dosing'}, {'measure': 'Multiple-dose administration: Accumulation ratio (Rac) of oxycodone, as data permit', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of oxycodone, as data permit', 'timeFrame': '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'}, {'measure': '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.', 'timeFrame': '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'}, {'measure': '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.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Maximum plasma concentration at steady state (Cmax,ss) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Minimum plasma concentration at steady state (Cmin,ss) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Average plasma concentration at steady state (Cave,ss) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Time to Reach Maximum Observed Plasma Concentration (Tmax) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Plasma Decay Half-Life (t1/2) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Peak to trough fluctuation at steady state (PTF) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Rac of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}, {'measure': 'Multiple-dose administration: Maximum Observed Plasma Concentration (Cmax) of noroxycodone and oxymorphone, as data permit.', 'timeFrame': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['single- and multiple-dose pharmacokinetics', 'ALO-02', 'OxyContin'], 'conditions': ['Management of Moderate to Severe Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4531006&StudyName=Pharmacokinetics%20Study%20of%20ALO-02%20and%20OxyContin%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant diseases.'}, 'identificationModule': {'nctId': 'NCT01557257', 'briefTitle': 'Pharmacokinetics Study of ALO-02 and OxyContin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'B4531006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '40 mg ALO-02 capsule', 'description': 'Single- and multiple-dose of 40 mg ALO-02 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: ALO-02', 'Drug: Naltrexone block']}, {'type': 'EXPERIMENTAL', 'label': '80 mg ALO-02 capsule', 'description': 'Single- and multiple-dose of 80 mg ALO-02 capsule under 50 mg naltrexone block', 'interventionNames': ['Drug: ALO-02', 'Drug: Naltrexone block']}, {'type': 'EXPERIMENTAL', 'label': '40 mg OxyContin tablet', 'description': 'Single- and multiple-dose of 40 mg OxyContin tablet under 50 mg naltrexone block', 'interventionNames': ['Drug: OxyContin', 'Drug: Naltrexone block']}], 'interventions': [{'name': 'ALO-02', 'type': 'DRUG', 'description': 'Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily)', 'armGroupLabels': ['40 mg ALO-02 capsule']}, {'name': 'Naltrexone block', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['40 mg ALO-02 capsule']}, {'name': 'ALO-02', 'type': 'DRUG', 'description': 'Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily)', 'armGroupLabels': ['80 mg ALO-02 capsule']}, {'name': 'Naltrexone block', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['80 mg ALO-02 capsule']}, {'name': 'OxyContin', 'type': 'DRUG', 'description': 'Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily)', 'armGroupLabels': ['40 mg OxyContin tablet']}, {'name': 'Naltrexone block', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['40 mg OxyContin tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}