Nctid:
NCT06615570
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2025-01-08"}, "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"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-10-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-10", "type"=>"ESTIMATED"}}, "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 30"}, {"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 85"}], "secondaryOutcomes"=>[{"measure"=>"Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973", "timeFrame"=>"From Day 1 up to Day 30"}, {"measure"=>"Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973", "timeFrame"=>"From Day 1 up to Day 85"}, {"measure"=>"Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973", "timeFrame"=>"From Day 1 up to Day 30"}, {"measure"=>"Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973", "timeFrame"=>"From Day 1 up to Day 85"}, {"measure"=>"Part A: Time Taken for VX-973 to Reach Maximum Concentration (tmax)", "timeFrame"=>"From Day 1 up to Day 30"}, {"measure"=>"Part B: Time Taken for VX-973 to Reach Maximum Concentration (tmax)", "timeFrame"=>"From Day 1 up to Day 85"}, {"measure"=>"Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test", "timeFrame"=>"From Day 1 up to Day 53"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 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* Participants of non-childbearing potential\n* Nonsmoker or ex-smoker for at least 3 months before screening\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"=>"NCT06615570", "briefTitle"=>"A Phase 1 Dose Escalation Study of VX-973 in Healthy Participants", "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 VX-973 in Healthy Adults", "orgStudyIdInfo"=>{"id"=>"VX24-973-002"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Part A: Single Ascending Dose", "description"=>"Participants will be randomized to receive a single dose of VX-973 under fasted conditions.", "interventionNames"=>["Drug: VX-973"]}, {"type"=>"EXPERIMENTAL", "label"=>"Part B: Multiple Ascending Dose", "description"=>"Participants will be randomized to receive multiple doses of VX-973 under fasted conditions.", "interventionNames"=>["Drug: VX-973"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Part A", "description"=>"Participants will be randomized to receive placebo matched to VX-973.", "interventionNames"=>["Drug: Placebo"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo Part B", "description"=>"Participants will be randomized to receive placebo matched to VX-973.", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"VX-973", "type"=>"DRUG", "description"=>"Suspension for oral administration.", "armGroupLabels"=>["Part A: Single Ascending Dose", "Part B: Multiple Ascending Dose"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Suspension for oral administration.", "armGroupLabels"=>["Placebo Part A", "Placebo Part B"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"84124", "city"=>"Salt Lake City", "state"=>"Utah", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"ICON Salt Lake City", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}], "centralContacts"=>[{"name"=>"Medical Information", "role"=>"CONTACT", "email"=>"medicalinfo@vrtx.com", "phone"=>"617-341-6777"}]}, "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"}}}}