Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-30 @ 4:59 PM
Study NCT ID:
NCT05851157
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2023-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite', 'timeFrame': 'Pre-dose up to Day 35 Post-dose'}, {'measure': 'Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite', 'timeFrame': 'Pre-dose up to Day 35 Post-dose'}, {'measure': 'Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite', 'timeFrame': 'Pre-dose up to Day 35 Post-dose'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Day 1 up to Day 44'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.', 'detailedDescription': 'This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\\^2)\n* A total body weight greater than (\\>) 50 kilogram (kg)\n\nKey Exclusion Criteria:\n\n* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug\n* Any condition possibly affecting drug absorption\n* Participants of childbearing potential\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05851157', 'briefTitle': 'A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 1, Randomized, Open-label, Crossover Study Evaluating the Effects of Food on the Pharmacokinetics of VX-548 in Healthy Adults', 'orgStudyIdInfo': {'id': 'VX22-548-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VX-548', 'description': 'Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.', 'interventionNames': ['Drug: VX-548']}], 'interventions': [{'name': 'VX-548', 'type': 'DRUG', 'otherNames': ['Suzetrigine'], 'description': 'Tablets for oral administration.', 'armGroupLabels': ['VX-548']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vertex Pharmaceuticals Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}