protocolSection identificationModule nctId: NCT06290466, orgStudyIdInfo id: FCN-437c-CP-004, briefTitle: Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2023-02-08, completionDateStruct date: 2023-02-08, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Ahon Pharmaceutical Co., Ltd., class: OTHER, descriptionModule briefSummary: This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule.This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control.This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Low dose group, interventions name: High dose group, outcomesModule primaryOutcomes measure: ΔΔQTcF, secondaryOutcomes measure: adverse events, secondaryOutcomes measure: Physical examination, secondaryOutcomes measure: Axillary temperature, secondaryOutcomes measure: blood pressure, secondaryOutcomes measure: pulse, secondaryOutcomes measure: Ecg monitoring and electrocardiogram, secondaryOutcomes measure: laboratory examination, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, secondaryOutcomes measure: Plasma concentration and pharmacokinetic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False