Nctid:
NCT06226454
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "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"=>39}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-01-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-07", "completionDateStruct"=>{"date"=>"2024-06-12", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-07-11", "studyFirstSubmitDate"=>"2023-12-20", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-07-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-06-12", "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"=>"From 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"=>"From Day 1 up to Day 43"}], "secondaryOutcomes"=>[{"measure"=>"Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993", "timeFrame"=>"Day 1 up to Day 16"}, {"measure"=>"Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993", "timeFrame"=>"Day 1 up to Day 16"}, {"measure"=>"Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993", "timeFrame"=>"Day 1 up to Day 43"}, {"measure"=>"Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993", "timeFrame"=>"Day 1 up to Day 43"}, {"measure"=>"Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test", "timeFrame"=>"Day 1 up to Day 11"}]}, "oversightModule"=>{"isUsExport"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of 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)\n* A total body weight of more than (\\>) 50 kg\n* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose\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, distribution, metabolism, or excretion\n\nOther protocol defined Inclusion/Exclusion criteria may apply."}, "identificationModule"=>{"nctId"=>"NCT06226454", "briefTitle"=>"A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics, of VX-993", "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, Pharmacokinetics, and Pharmacodynamics of Oral VX-993 in Healthy Adult Subjects", "orgStudyIdInfo"=>{"id"=>"VX23-993-003"}}, "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"=>"PLACEBO_COMPARATOR", "label"=>"Part A: Placebo", "description"=>"Participants will be randomized to receive placebo matched to VX-993.", "interventionNames"=>["Drug: Placebo"]}, {"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"=>"Part B: Placebo", "description"=>"Participants will be randomized to receive placebo matched to VX-993.", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"VX-993", "type"=>"DRUG", "description"=>"Suspension for oral administration.", "armGroupLabels"=>["Part A: Single Ascending Dose (SAD)", "Part B: Multiple Ascending Dose (MAD)"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Suspension for oral administration.", "armGroupLabels"=>["Part A: Placebo", "Part B: Placebo"]}]}, "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"}}}}
