Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT02046850
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2014-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C517975', 'term': 'AZD 6244'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2014-01-24', 'studyFirstSubmitQcDate': '2014-01-24', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety variables (adverse events, physical examinations, ophthalmologic assessments, vital signs, clinical laboratory assessments, and 12 lead electrocardiograms)', 'timeFrame': 'Baseline (Day-1) up to Day 25', 'description': 'Assessments performed during each of the 3 treatments'}], 'primaryOutcomes': [{'measure': 'Pharmacokinetics of selumetinib by assessment of area under the plasma concentration-time curve from time zero to infinity (AUC)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of area under the plasma concentration-time from time zero to the time of the last quantifiable concentration (AUC(0-t)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of area under the plasma concentration-time curve from time zero to 12 hours post-dose AUC(0-12)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of maximum plasma concentration (Cmax)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of time to Cmax (tmax)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, by assessment of apparent systemic plasma clearance (CL/F)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, by assessment of apparent volume at distribution equilibrium, mean residence time (MRT)*CL/F (Vss/F)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, by assessment of apparent volume at distribution (Vz/F)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of terminal half-life (t1/2)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib, N-desmethyl selumetinib,(and the amide metabolite, if deemed appropriate) by assessment of terminal rate constant (λz)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assessment of AUC metabolite to parent ratio, n-desmethyl selumetinib (MRAUC)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib and N-desmethyl selumetinib by assessment of Cmax metabolite to parent ratio, n-desmethyl selumetinib (MRCmax)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}, {'measure': 'Pharmacokinetics of selumetinib by assessment of mean residence time (MRT)', 'timeFrame': 'Blood samples are collected pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours post dose', 'description': 'Samples taken during each of the 3 treatments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I, healthy, pharmacokinetics,'], 'conditions': ['Solid Tumours']}, 'descriptionModule': {'briefSummary': 'Study to assess the effect of Rifampicin on the pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers', 'detailedDescription': 'A Open-label, Single-center Study to Assess the Effect of the CYP3A4 inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: 1. Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). 2. Must not have smoked or used nicotine products within the previous 3 months. 3. Have a calculated creatinine clearance (CrCL) greater than 50 mL/min using the Cockcroft-Gault formula.\n\nExclusion Criteria: 1. Subjects of Japanese or non-Japanese Asian ethnicity. 2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam and Malaysia). Asian Indians are acceptable. 3. Current or past history of central serous retinopathy or retinal vein thrombosis,intra-ocular pressure greater than 21 mmHg or uncontrolled glaucoma. 4. Any clinically relevant abnormal findings in physical examination, hematology, clinical chemistry, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. 5. History of presence of any clinically significant disease or disorder in the opinion of the investigator.'}, 'identificationModule': {'nctId': 'NCT02046850', 'briefTitle': 'To Assess the Effect of Rifampicin on the Pharmacokinetics of Selumetinib in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I Open-label, Single-center Study to Assess the Effect of the CYP3A4 Inducer Rifampicin on the Pharmacokinetics of a 75 mg Single Oral Dose of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Volunteers Aged 18 to 45 Years', 'orgStudyIdInfo': {'id': 'D1532C00085'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'selumetinib 75mg.', 'description': 'Volunteers will receive selumetinib 75mg administered by mouth, as a capsule', 'interventionNames': ['Drug: selumetinib']}, {'type': 'OTHER', 'label': 'rifampicin 600mg.', 'description': 'Volunteers will receive rifampicin 600mg administered by mouth, as a capsule', 'interventionNames': ['Drug: rifampicin']}, {'type': 'EXPERIMENTAL', 'label': 'selumetinib 75mg and rifampicin 600mg', 'description': 'Volunteers will receive selumetinib 75mg and rifampicin 600mg, by mouth, as a capsule', 'interventionNames': ['Drug: selumetinib', 'Drug: rifampicin']}], 'interventions': [{'name': 'selumetinib', 'type': 'DRUG', 'otherNames': ['AZD6244'], 'description': 'Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).', 'armGroupLabels': ['selumetinib 75mg.']}, {'name': 'rifampicin', 'type': 'DRUG', 'otherNames': ['AZD6244'], 'description': 'Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).', 'armGroupLabels': ['rifampicin 600mg.']}, {'name': 'selumetinib', 'type': 'DRUG', 'description': 'On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C).', 'armGroupLabels': ['selumetinib 75mg and rifampicin 600mg']}, {'name': 'rifampicin', 'type': 'DRUG', 'description': 'On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C).', 'armGroupLabels': ['selumetinib 75mg and rifampicin 600mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Eleanor Lisbon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quintiles 6700 W 115th Street, Kansas, US'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}