Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
Study NCT ID:
NCT01931761
Status:
COMPLETED
Last Update Posted:
2015-06-30
First Post:
2013-08-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615234', 'term': 'Carbon-14'}, {'id': 'C517975', 'term': 'AZD 6244'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2015-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of total radioactivity in blood and plasma and percentage of radioactive dose in urine and faeces and total balance', 'timeFrame': 'Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days'}], 'secondaryOutcomes': [{'measure': 'Metabolite profiling and identification in plasma and excreta', 'timeFrame': 'Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.'}, {'measure': 'Pharmacokinetic parameters of selumetinib', 'timeFrame': 'Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days.', 'description': 'Cmax, tmax, t½, AUC, CL/F, Vz/F, MRT, fe, Ae, CLR'}, {'measure': 'Plasma concentrations of selumetinib', 'timeFrame': 'Samples collected prior to treatment, during treatment and follow-up for a maximum of 14 days'}, {'measure': 'Safety', 'timeFrame': 'Assessments prior to treatment and after treatment including follow up.', 'description': 'Adverse events, vital signs, electrocardiogram, haematology, clinical chemistry, urinalysis, physical examination, left ventricular ejection fraction, and opthalmology assessments.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics, mass balance, AZD6244'], 'conditions': ['Solid Tumours']}, 'referencesModule': {'references': [{'pmid': '27751676', 'type': 'DERIVED', 'citation': 'Dymond AW, Howes C, Pattison C, So K, Mariani G, Savage M, Mair S, Ford G, Martin P. Metabolism, Excretion, and Pharmacokinetics of Selumetinib, an MEK1/2 inhibitor, in Healthy Adult Male Subjects. Clin Ther. 2016 Nov;38(11):2447-2458. doi: 10.1016/j.clinthera.2016.09.002. Epub 2016 Oct 15.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1869&filename=CSR_Synopsis_D1532C00077.pdf', 'label': 'CSR\\_Synopsis\\_D1532C00077.pdf'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the absorption, distribution, metabolism and excretion (ADME) of single dose \\[14C\\] selumetinib in volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures.\n* Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive.\n* Regular bowel movements (ie, on average production of at least 1 stool per day).\n\nExclusion Criteria:\n\n* Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma.\n* Exposure to radiation levels above background exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.\n* History or presence of any clinically significant disease or disorder in the opinion of the investigator\n* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, vital signs or ECG at baseline in the opinion of the Investigator.'}, 'identificationModule': {'nctId': 'NCT01931761', 'briefTitle': 'Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C] Selumetinib in Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single-centre, Non-randomised, Open-label, Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-Selumetinib in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D1532C00077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[C14] selumetinib 75mg single dose', 'description': '\\[C14\\] selumetinib 75mg single dose', 'interventionNames': ['Drug: [C14] selumetinib (oral)']}], 'interventions': [{'name': '[C14] selumetinib (oral)', 'type': 'DRUG', 'otherNames': ['Selumetinib'], 'description': 'Single oral administration \\[C14\\] 75mg', 'armGroupLabels': ['[C14] selumetinib 75mg single dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ruddington', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Stuart Mair, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aberdeen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}