Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-29 @ 11:34 PM
Study NCT ID:
NCT05581758
Status:
COMPLETED
Last Update Posted:
2025-03-05
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706028', 'term': 'sotorasib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of AMG 510', 'timeFrame': 'Day 1 and Day 4'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510', 'timeFrame': 'Day 1 and Day 4'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510', 'timeFrame': 'Day 1 and Day 4'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with an Adverse Event (AE)', 'timeFrame': 'Day 1 to Day 6', 'description': 'Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs.'}, {'measure': 'Cmax of AMG 510 Metabolite M24', 'timeFrame': 'Day 1 and Day 4'}, {'measure': 'AUClast of AMG 510 Metabolite M24', 'timeFrame': 'Day 1 and Day 4'}, {'measure': 'AUCinf of AMG 510 Metabolite M24', 'timeFrame': 'Day 1 and Day 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Participants', 'AMG 510', 'Sotorasib'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.\n* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.\n* Females of nonchildbearing potential.\n\nExclusion Criteria:\n\n* Inability to swallow oral medication or history of malabsorption syndrome.\n* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.\n* Poor peripheral venous access.\n* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.'}, 'identificationModule': {'nctId': 'NCT05581758', 'briefTitle': 'A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects', 'orgStudyIdInfo': {'id': '20190316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence AB', 'description': 'Participants will be administered AMG 510 orally in the following order:\n\nPeriod 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions.', 'interventionNames': ['Drug: AMG 510']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BA', 'description': 'Participants will be administered AMG 510 orally in the following order:\n\nPeriod 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions.', 'interventionNames': ['Drug: AMG 510']}], 'interventions': [{'name': 'AMG 510', 'type': 'DRUG', 'otherNames': ['Sotorasib'], 'description': 'Oral Tablet', 'armGroupLabels': ['Treatment Sequence AB', 'Treatment Sequence BA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}