[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636784":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":40,"overallOfficials":20,"centralContacts":20,"locations":46,"responsibleParty":57,"collaborators":20,"id":59,"slug":20,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":20,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Onconic Therapeutics Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":20},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Maximum Plasma Concentration (Cmax) of JPI-547","Cmax is defined as the maximum observed plasma concentration of JPI-547 after a single oral administration.","Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean\u002FCaucasian fed\u002Ffasted crossover arm and up to Day 6 for the Chinese fasted arm.",{"measure":14,"description":15,"timeFrame":12},"Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547","AUClast is defined as the area under the plasma concentration-time curve from time zero to the last quantifiable concentration of JPI-547 after a single oral administration.",{"measure":17,"description":18,"timeFrame":19},"Number of Participants With Abnormalities in Safety and Tolerability Assessments","Safety and tolerability will be assessed by monitoring adverse events, including subjective and objective symptoms, physical examinations, vital signs, 12-lead electrocardiograms, and clinical laboratory tests after a single oral administration of JPI-547.","From the first administration of JPI-547 until the Post-Study Visit; assessed up to Day 32 for the Korean\u002FCaucasian fed\u002Ffasted crossover arm and up to Day 18 for the Chinese fasted arm.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","CROSSOVER","This study consists of 2 cohorts. Cohort 1 is a randomized, open-label, crossover study to evaluate the food effect of JPI-547 in healthy Korean and Caucasian male participants. Cohort 2 is an open-label, single-dose study to explore ethnic differences in the pharmacokinetics and safety\u002Ftolerability of JPI-547 in healthy Chinese male participants under fasted conditions.","BASIC_SCIENCE",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","1. Cohort 1 is designed to evaluate the effect of food on the pharmacokinetics and safety\u002Ftolerability of JPI-547 in healthy Korean and Caucasian participants under fasted and fed conditions.\n2. Cohort 2 is designed to explore the effect of ethnicity on the pharmacokinetics and safety\u002Ftolerability of JPI-547 in healthy Chinese participants after a single oral administration.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Korean\u002FCaucasian Participants: JPI-547 Fed\u002FFasted Crossover","EXPERIMENTAL","Healthy Korean and Caucasian male participants receive a single oral dose of JPI-547 in each treatment period under fed and fasted conditions in a crossover design.",[35],"Drug: JPI-547",{"label":37,"type":32,"description":38,"interventionNames":39},"Chinese Participants: JPI-547 Fasted","Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions.",[35],[41],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":20},"DRUG","JPI-547","JPI-547 is administered orally as a single dose per administration.",[37,31],[47],{"facility":48,"status":20,"city":49,"state":20,"zip":20,"country":50,"countryCode":20,"cosmosGeoPoint":51,"geoPoint":56,"contacts":20},"Seoul National University Hospital","Seoul","South Korea",{"type":52,"coordinates":53},"Point",[54,55],126.9784,37.566,{"lat":55,"lon":54},{"type":58,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100636784",false,"NCT07570186","Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants","A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety\u002FTolerability of JPI-547 After a Single Oral Administration in Healthy Male Korean, Caucasian and Chinese Participants","Inclusion Criteria:\n\n* Healthy Korean, Caucasian, or Chinese male participants aged 19 to 50 years at screening\n* Body weight between 50.0 and 90.0 kg and BMI between 18.5 and 29.9 kg\u002Fm²\n* Able to understand the study and provide written informed consent\n* Considered suitable for study participation by the investigator based on medical history, physical examination, and clinical laboratory tests\n\nExclusion Criteria:\n\n* Clinically significant medical or surgical history\n* Gastrointestinal disease or surgery affecting drug absorption\n* Hypersensitivity to PARP inhibitors or other significant drug allergy\n* Drug abuse history or positive drug screening\n* Clinically significant abnormal vital signs or laboratory results\n* Positive viral or serologic screening tests\n* Recent use of prohibited medications\n* Recent participation in another clinical trial\n* Recent blood donation or transfusion\n* Inability to abstain from smoking, alcohol, caffeine, or grapefruit\n* Failure to comply with contraception or sperm donation requirements\n* Any condition making the participant unsuitable in the investigator's judgment",true,"MALE","19 Years","50 Years",{"count":70,"type":71},36,"ESTIMATED","INTERVENTIONAL",[74],"PHASE1","This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety\u002Ftolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants.",[77],"Healthy Volunteers",[43,79,80,81],"Food Effect","Ethnicity","Pharmacokinetics","NOT_YET_RECRUITING","2026-04-29",{"date":85,"type":86},"2026-05-06","ACTUAL",{"date":88,"type":71},"2026-05",{"date":90,"type":71},"2026-07",{"name":5,"class":6},1]