Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-09 @ 1:47 AM
Study NCT ID:
NCT02974361
Status:
COMPLETED
Last Update Posted:
2017-05-03
First Post:
2016-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-22', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '12 hours'}, {'measure': 'AUC(0-inf)', 'timeFrame': '12 hours'}]}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen.\n\nThis study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B \\& Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively.\n\nA total of 30 subjects will take part in the study; 10 per study part.\n\nThe key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects\n* BMI 18 - 30 kg/m2\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence or history of significant renal, hepatic, gastrointestinal, central nervous system, respiratory, cardiovascular, autoimmune or metabolic dysfunction\n* Recent or concurrent use of prescription or non-prescription medications, other than contraceptives\n* Allergy or sensitivity to NSAIDs'}, 'identificationModule': {'nctId': 'NCT02974361', 'briefTitle': 'Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oxford Pharmascience Ltd'}, 'officialTitle': 'An Open-label, Single-dose, Randomised, Crossover Study to Evaluate Changes in the Pharmacokinetics of Ibuprofen From Ibuprofen-LDH Dosed With and Without Release Modifying Excipients in Normal, Healthy, Adult Subjects', 'orgStudyIdInfo': {'id': 'OAT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part A Ibuprofen control', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Ibuprofen-LDH', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Ibuprofen-LDH Excipient Combo 1', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Ibuprofen-LDH Excipient Combo 2', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Ibuprofen-LDH Excipient Combo 3', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Ibuprofen-LDH Excipient Combo 4', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part A Ibuprofen Lysine', 'interventionNames': ['Drug: Ibuprofen Lysine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Ibuprofen LDH Excipient Combo 1', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Ibuprofen LDH Excipient Combo 2', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Ibuprofen LDH Excipient Combo 3', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Ibuprofen LDH Excipient Combo 4', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part C Ibuprofen', 'interventionNames': ['Drug: Ibuprofen']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Ibuprofen LDH Excipient Combo 1', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Ibuprofen LDH Excipient Combo 2', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Ibuprofen LDH Excipient Combo 3', 'interventionNames': ['Drug: Ibuprofen-LDH']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Ibuprofen LDH Excipient Combo 5', 'interventionNames': ['Drug: Ibuprofen-LDH']}], 'interventions': [{'name': 'Ibuprofen', 'type': 'DRUG', 'armGroupLabels': ['Part A Ibuprofen control', 'Part B Ibuprofen', 'Part C Ibuprofen']}, {'name': 'Ibuprofen Lysine', 'type': 'DRUG', 'armGroupLabels': ['Part A Ibuprofen Lysine']}, {'name': 'Ibuprofen-LDH', 'type': 'DRUG', 'armGroupLabels': ['Part A Ibuprofen-LDH', 'Part A Ibuprofen-LDH Excipient Combo 1', 'Part A Ibuprofen-LDH Excipient Combo 2', 'Part A Ibuprofen-LDH Excipient Combo 3', 'Part A Ibuprofen-LDH Excipient Combo 4', 'Part B Ibuprofen LDH Excipient Combo 1', 'Part B Ibuprofen LDH Excipient Combo 2', 'Part B Ibuprofen LDH Excipient Combo 3', 'Part B Ibuprofen LDH Excipient Combo 4', 'Part B Ibuprofen LDH Excipient Combo 5', 'Part C Ibuprofen LDH Excipient Combo 1', 'Part C Ibuprofen LDH Excipient Combo 2', 'Part C Ibuprofen LDH Excipient Combo 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF48 4DR', 'city': 'Merthyr Tydfil', 'country': 'United Kingdom', 'facility': 'Simbec Orion Ltd', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'overallOfficials': [{'name': 'Annelize Koch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simbec Orion Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford Pharmascience Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}