{"id":"bilastine-ketoconazole","phase":"phase_1","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT00419783"],"aliases":[],"patents":[],"pricing":[],"modality":"Small molecule","timeline":[],"aiSummary":"Bilastine is a small molecule that acts as an inverse agonist at the Histamine H1 receptor. Bilastine & Ketoconazole was studied in a randomized, multiple dose, double-blind, 5-way crossover study to assess its electrocardiographic effects in healthy individuals.","brandName":"Bilastine & Ketoconazole","companyId":"faes-farma-s-a","mechanism":{"target":"Histamine H1 receptor (bilastine), CYP3A4 and fungal lanosterol 14α-demethylase (ketoconazole)","novelty":"","modality":"Small molecule","drugClass":"","explanation":"Bilastine is a selective histamine H1 receptor antagonist that prevents histamine-mediated allergic symptoms. Ketoconazole inhibits fungal cytochrome P450 enzyme lanosterol 14α-demethylase and also strongly inhibits human CYP3A4, making it useful for studying drug-drug interactions with bilastine metabolism.","oneSentence":"Bilastine blocks histamine H1 receptors to prevent allergic responses; ketoconazole inhibits fungal ergosterol synthesis and CYP3A4 metabolism.","technicalDetail":""},"commercial":null,"_claudeStub":{"ts":1779123165,"model":"claude-sonnet-4-5-20250929"},"companyName":"Faes Farma, S.A.","competitors":[],"description":"Bilastine and ketoconazole is a Phase 1 drug-drug interaction study combination being investigated by Faes Farma. Bilastine is a second-generation antihistamine, while ketoconazole is an antifungal agent that also acts as a strong CYP3A4 inhibitor used in pharmacokinetic studies.","genericName":"Bilastine & Ketoconazole","indications":{"approved":[{"status":"investigational","condition":"Drug-drug interaction study","patientPopulation":"Healthy volunteers"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"trialDetails":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"rwe":[],"genericFilers":[],"relatedDrugs":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":false,"score":2}}