Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT06394167
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2024-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-04-26', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Day 16'}, {'measure': 'Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Day 43'}], 'secondaryOutcomes': [{'measure': 'Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993', 'timeFrame': 'Pre-dose up to Day 16'}, {'measure': 'Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993', 'timeFrame': 'Pre-dose up to Day 43'}, {'measure': 'Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993', 'timeFrame': 'Pre-dose up to Day 16'}, {'measure': 'Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993', 'timeFrame': 'Pre-dose up to Day 43'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses 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'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\\^2), inclusive\n* A total body weight of more than (\\>) 50 kg\n* Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug\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 distribution, metabolism, or excretion\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06394167', 'briefTitle': 'A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vertex Pharmaceuticals Incorporated'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety and Pharmacokinetics of Intravenous VX-993 in Healthy Adults', 'orgStudyIdInfo': {'id': 'VX23-993-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Single Ascending Dose (SAD)', 'description': 'Participants will be randomized to receive a single dose of different dose levels of VX-993.', 'interventionNames': ['Drug: VX-993']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Multiple Ascending Dose (MAD)', 'description': 'Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.', 'interventionNames': ['Drug: VX-993']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part A', 'description': 'Participants will be randomized to receive placebo matched to VX-993.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Part B', 'description': 'Participants will be randomized to receive multiple doses of placebo matched to VX-993.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VX-993', 'type': 'DRUG', 'description': 'Solution for IV administration.', 'armGroupLabels': ['Part A: Single Ascending Dose (SAD)', 'Part B: Multiple Ascending Dose (MAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for IV administration.', 'armGroupLabels': ['Placebo Part A', 'Placebo Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, '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'}}}}