Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-24 @ 9:29 AM
Study NCT ID:
NCT02133820
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2014-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2014-02-25', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics parameters AUC and Cmax', 'timeFrame': 'Up to 32 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '7 to 10 days', 'description': 'AEs will be recorded through spontaneous reporting'}, {'measure': 'Vital Signs', 'timeFrame': '0 to 32 hours', 'description': 'Vital signs - blood pressure, pulse rate, tympanic temperature and respiration rate'}, {'measure': 'Clinical Laboratory Tests', 'timeFrame': 'Day 0 and Day 7-10', 'description': 'Clinical laboratory tests - blood samples will be taken at screening and post-study medical for routine laboratory analysis (haematology, blood chemistry and urinalysis'}, {'measure': 'ECG', 'timeFrame': 'Screening, 1 our post-dose and Day 7-10', 'description': 'ECGs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'Pharmacokinetics'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.', 'detailedDescription': 'This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.\n\nDetermination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.'}, 'identificationModule': {'nctId': 'NCT02133820', 'briefTitle': 'A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mundipharma Research Limited'}, 'officialTitle': 'A 4-part, Single-dose, Open-label, Randomised, Crossover, Exploratory Study in Healthy Subjects to Assess the Influence of an Opioid Antagonist on How the Body Processes a Strong Painkiller, When Co-administered in a Fasted and Fed State.', 'orgStudyIdInfo': {'id': 'HMX1507'}, 'secondaryIdInfos': [{'id': '2013-005522-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '12 hourly capsule fasted', 'description': '4 mg 12 hourly capsule - strong pain killer fasted', 'interventionNames': ['Drug: 4 mg 12 hourly capsule - strong pain killer fed']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12 hourly capsule fed', 'description': '4 mg 12 hourly capsule - strong pain killer fed', 'interventionNames': ['Drug: 4 mg 12 hourly capsule - strong pain killer fasted']}, {'type': 'EXPERIMENTAL', 'label': '12 hourly capsule with antagonist fasted', 'description': '4 mg 12 hourly capsule strong painkiller with antagonist fasted', 'interventionNames': ['Drug: 4 mg 12 hourly capsule strong painkiller with antagonist fed']}, {'type': 'EXPERIMENTAL', 'label': '12 hourly capsule with antagonist fed', 'description': '4 mg 12 hourly capsule strong painkiller with antagonist fed', 'interventionNames': ['Drug: 12 hourly capsule strong painkiller with antagonist fasted)']}], 'interventions': [{'name': '4 mg 12 hourly capsule - strong pain killer fasted', 'type': 'DRUG', 'otherNames': ['MR2XXX'], 'armGroupLabels': ['12 hourly capsule fed']}, {'name': '4 mg 12 hourly capsule - strong pain killer fed', 'type': 'DRUG', 'otherNames': ['MR2XXX'], 'armGroupLabels': ['12 hourly capsule fasted']}, {'name': '12 hourly capsule strong painkiller with antagonist fasted)', 'type': 'DRUG', 'otherNames': ['MR2XXX'], 'armGroupLabels': ['12 hourly capsule with antagonist fed']}, {'name': '4 mg 12 hourly capsule strong painkiller with antagonist fed', 'type': 'DRUG', 'otherNames': ['MR2XXX'], 'armGroupLabels': ['12 hourly capsule with antagonist fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Quotient Clinical Limited', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mundipharma Research Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}