Nctid:
NCT06232109
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000017964", "term"=>"Itraconazole"}, {"id"=>"D000016666", "term"=>"Fluvoxamine"}, {"id"=>"D000017374", "term"=>"Paroxetine"}], "ancestors"=>[{"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D000065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D000006727", "term"=>"Hormone Antagonists"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D000017367", "term"=>"Selective Serotonin Reuptake Inhibitors"}, {"id"=>"D000014179", "term"=>"Neurotransmitter Uptake Inhibitors"}, {"id"=>"D000049990", "term"=>"Membrane Transport Modulators"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000018490", "term"=>"Serotonin Agents"}, {"id"=>"D000018687", "term"=>"Antidepressive Agents, Second-Generation"}, {"id"=>"D000000928", "term"=>"Antidepressive Agents"}, {"id"=>"D000011619", "term"=>"Psychotropic Drugs"}, {"id"=>"D000065690", "term"=>"Cytochrome P-450 CYP2D6 Inhibitors"}, {"id"=>"D000014151", "term"=>"Anti-Anxiety Agents"}, {"id"=>"D000014149", "term"=>"Tranquilizing Agents"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000065609", "term"=>"Cytochrome P-450 CYP1A2 Inhibitors"}, {"id"=>"D000065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}], "browseLeaves"=>[{"id"=>"M20133", "name"=>"Itraconazole", "asFound"=>"Increasing", "relevance"=>"HIGH"}, {"id"=>"M256158", "name"=>"Hydroxyitraconazole", "relevance"=>"LOW"}, {"id"=>"M19035", "name"=>"Fluvoxamine", "asFound"=>"Niacin", "relevance"=>"HIGH"}, {"id"=>"M19654", "name"=>"Paroxetine", "asFound"=>"Pharmacist", "relevance"=>"HIGH"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M15512", "name"=>"Serotonin", "relevance"=>"LOW"}, {"id"=>"M19649", "name"=>"Selective Serotonin Reuptake Inhibitors", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M4247", "name"=>"Antidepressive Agents", "relevance"=>"LOW"}, {"id"=>"M14474", "name"=>"Psychotropic Drugs", "relevance"=>"LOW"}, {"id"=>"M16905", "name"=>"Anti-Anxiety Agents", "relevance"=>"LOW"}, {"id"=>"T2", "name"=>"Asparagine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-22", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-05-13", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-23", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-13", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Cmax of ASN51", "timeFrame"=>"Up to Day 15"}, {"measure"=>"Tmax of ASN51", "timeFrame"=>"Up to Day 15"}, {"measure"=>"AUC0-tau of ASN51", "timeFrame"=>"Up to Day 15"}, {"measure"=>"AUC0-inf of ASN51", "timeFrame"=>"Up to Day 15"}, {"measure"=>"t1/2 of ASN51", "timeFrame"=>"Up to Day 15"}, {"measure"=>"λz of ASN51", "timeFrame"=>"Up to Day 15"}], "secondaryOutcomes"=>[{"measure"=>"Number of participants with adverse events", "timeFrame"=>"Up to Day 22"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Drug Drug Interaction"]}, "descriptionModule"=>{"briefSummary"=>"The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Key Inclusion Criteria:\n\n* Healthy males or females of nonchildbearing potential\n* Aged 18-55 years (inclusive) at time of Screening\n* Deemed healthy based on medical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine\n* Body weight ≥ 50.0 kg (men) or ≥ 45.0 kg (women) at Screening\n* Body mass index (BMI); Quetelet index in the range 18.0-30.9 kg/m2 (inclusive) at Screening\n\nKey Exclusion Criteria:\n\n* Clinically relevant abnormal medical history, physical or neurological findings, ECG, or laboratory values at Screening, or before the first dose of any study medication, that could interfere with the objectives of the study or the safety of the subject\n* History or presence of acute or chronic illness, or clinically-significant medical abnormality, sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous\n* History or presence of any disease, medical condition, or surgery (e.g., stomach bypass), likely to affect the absorption, distribution, metabolism, or excretion of medicines. Subjects with a history of cholecystectomy\n* Presence or history of severe or clinically significant adverse reaction to any drug; or a history of sensitivity to ASN51 (all subjects), or any components of the medications\n* Receipt of an investigational product or device within 6 weeks (or 5 half-lives, or twice the duration of the biological effect, of the investigational product, if known - whichever is longer) before the first dose of study medication; in the follow-up period of another clinical study at the time of Screening for this study\n* Use of a prescription medicine during the 14 days (or 5 half-lives of the medicine, if known - whichever is longer) before the first dose of study medication\n* Use of an over-the-counter medicine, including vitamins, herbal, or dietary supplements (including St John's Wort), with the exception of acetaminophen (paracetamol), during the 7 days (or 5 half-lives of the medicine, if known - whichever is longer, or 28 days if the medicine is a potential hepatic enzyme inducer) before the first dose of study medication\n* Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"}, "identificationModule"=>{"nctId"=>"NCT06232109", "briefTitle"=>"Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Asceneuron S.A."}, "officialTitle"=>"Phase 1, Open-Label, Parallel Group Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP2C19 Inhibitor), Itraconazole (CYP3A4 Inhibitor) and Paroxetine (CYP2D6 Inhibitor) on the Pharmacokinetics of ASN51 in Healthy Subjects", "orgStudyIdInfo"=>{"id"=>"ASN51-104"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"ASN51"}, {"type"=>"EXPERIMENTAL", "label"=>"ASN51 + Fluvoxamine", "interventionNames"=>["Drug: Fluvoxamine", "Drug: ASN51"]}, {"type"=>"EXPERIMENTAL", "label"=>"ASN51 + Itraconazole", "interventionNames"=>["Drug: Itraconazole", "Drug: ASN51"]}, {"type"=>"EXPERIMENTAL", "label"=>"ASN51 + Paroxetine", "interventionNames"=>["Drug: Paroxetine", "Drug: ASN51"]}], "interventions"=>[{"name"=>"Fluvoxamine", "type"=>"DRUG", "description"=>"Oral", "armGroupLabels"=>["ASN51 + Fluvoxamine"]}, {"name"=>"Itraconazole", "type"=>"DRUG", "description"=>"Oral", "armGroupLabels"=>["ASN51 + Itraconazole"]}, {"name"=>"Paroxetine", "type"=>"DRUG", "description"=>"Oral", "armGroupLabels"=>["ASN51 + Paroxetine"]}, {"name"=>"ASN51", "type"=>"DRUG", "description"=>"Oral", "armGroupLabels"=>["ASN51 + Fluvoxamine", "ASN51 + Itraconazole", "ASN51 + Paroxetine"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"9728 NZ", "city"=>"Groningen", "status"=>"RECRUITING", "country"=>"Netherlands", "contacts"=>[{"name"=>"Stefab Slagter", "role"=>"CONTACT", "email"=>"Stefan.Slagter@iconplc.com", "phone"=>"+31 (0) 800-0292044"}, {"name"=>"Jeroen v Wetering, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"ICON Groningen Van Swietenlaan 6", "geoPoint"=>{"lat"=>53.21917, "lon"=>6.56667}}], "centralContacts"=>[{"name"=>"Rolf Pokorny, MD", "role"=>"CONTACT", "email"=>"rolf.pokorny@asceneuron.com", "phone"=>"+41 21 353 8245"}], "overallOfficials"=>[{"name"=>"Rolf Pokorny, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Asceneuron, SA"}, {"name"=>"Jeroen v Wetering, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"QPS Holdings LLC"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Asceneuron S.A.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
