[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612251":3},{"organization":4,"armGroups":7,"interventions":40,"overallOfficials":46,"centralContacts":63,"locations":69,"responsibleParty":85,"collaborators":46,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":46,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":46,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":72,"whyStopped":46,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Enyo Pharma","INDUSTRY",[8,14,19,23,29,34,37],{"label":9,"type":10,"description":11,"interventionNames":12},"Vonafexor low dose","EXPERIMENTAL","Vonafexor low dose 1 tablet per day",[13],"Drug: EYP651\u002FVonafexor low dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Vonafexor high dose","Vonafexor high dose 1 tablet per day",[18],"Drug: EYP651\u002FVonafexor high dose",{"label":20,"type":10,"description":21,"interventionNames":22},"EYP651 low dose","EYP651 low dose 1 tablet per day",[13],{"label":24,"type":10,"description":16,"interventionNames":25},"EYP651 high dose",[18,26,27,28],"Drug: EYP651\u002FCYP3A4 inhibitor","Drug: EYP651\u002FTransporter substrate","Drug: EYP651\u002FCYP2C8 and CYP2C9 substrate",{"label":30,"type":31,"description":32,"interventionNames":33},"CYP3A4 inhibitor","ACTIVE_COMPARATOR","Oral daily administration",[26],{"label":35,"type":31,"description":32,"interventionNames":36},"Transporter substrate",[27],{"label":38,"type":31,"description":32,"interventionNames":39},"CYP2C8 and CYP2C9 substrate",[28],[41,47,51,55,59],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"DRUG","EYP651\u002FVonafexor low dose","Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1",[20,9],null,{"type":42,"name":48,"description":49,"armGroupLabels":50,"otherNames":46},"EYP651\u002FVonafexor high dose","Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1",[24,15],{"type":42,"name":52,"description":53,"armGroupLabels":54,"otherNames":46},"EYP651\u002FCYP3A4 inhibitor","Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 1 (CYP3A4 inhibitor) in period 3. Parallel group 1",[30,24],{"type":42,"name":56,"description":57,"armGroupLabels":58,"otherNames":46},"EYP651\u002FTransporter substrate","Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 2 (Transporter substrate) in period 3. Parallel group 2",[24,35],{"type":42,"name":60,"description":61,"armGroupLabels":62,"otherNames":46},"EYP651\u002FCYP2C8 and CYP2C9 substrate","Repeated daily dosing with EYP651 alone in period 1, Repeated daily dosing with the index drug 3 alone in period 2 and combined administration repeated daily dosing of EYP651 with index drug 3 (CYP2C8 and CYP2C9 substrate) in period 3. Parallel group 3",[38,24],[64],{"name":65,"role":66,"phone":67,"phoneExt":46,"email":68},"Clinical project manager","CONTACT","+33 (0)4 37 70 02 19","mod@enyopharma.com",[70],{"facility":71,"status":72,"city":73,"state":46,"zip":46,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Eurofins Optimed","RECRUITING","Gières","France","FR",{"type":77,"coordinates":78},"Point",[79,80],5.78935,45.17997,{"lat":80,"lon":79},[83],{"name":84,"role":66,"phone":67,"phoneExt":46,"email":68},"Clinical Project Manager",{"type":86,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100612251","phase-1-pharmacokinetic-comparison-of-vonafexor-acid-and-its-lysine-salt-and-evaluation-of-potential-drug-drug-interactions-100612251",false,"NCT07251153","Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions","A Phase 1, Two Parts, Open-label, Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt (EYP651) in Healthy Volunteers and Evaluation of Potential Drug-Drug Interactions","Inclusion Criteria:\n\n* Healthy male or female subject, aged 18-65 years inclusive.\n* Females of childbearing potential: commitment to use a highly effective method of birth control which result in a low failure rate.\n\nFemales of non-childbearing potential: either at least 3 months surgically sterilized or at least 1-year postmenopausal confirmed by the follicle stimulating hormone (FSH) level.\n\nMales: commitment to use an adequate contraceptive method consistently and correctly.\n\n* Negative pregnancy test for childbearing potential women or FSH ≥ 40 IU\u002FmL for postmenopausal women.\n* Non-smoker subject or smoker of maximum 5 cigarettes a day and able to stop during the study.\n* Body Mass Index (BMI) between 18 and 30 kg\u002Fm2 inclusive.\n* Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal Blood Pressure and Heart Rate.\n* Normal ECG recording on a 12-lead ECG.\n* Laboratory parameters within the normal range of the laboratory (hematology, hemostasis, blood chemistry tests, urinalysis).\n* Normal dietary habits.\n* Signing a written informed consent prior to selection.\n* Covered by Health Insurance System and \u002F or in compliance with the recommendations of National Law in force relating to biomedical research.\n\nExclusion Criteria:\n\n* Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease.\n* Frequent headaches and \u002F or migraine, recurrent nausea and \u002F or vomiting.\n* Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension.\n* Blood donation in the 2 months before administration.\n* General anaesthesia in the 3 months before administration.\n* Presence or history of drug allergic condition and\u002For hypersensitivity.\n* Inability to abstain from intense muscular effort.\n* Any drug intake (except paracetamol and contraceptives) during the month prior to the first administration.\n* History or presence of drug or alcohol abuse (alcohol consumption \\> 40 grams \u002F day).\n* Excessive consumption of beverages with xanthine bases (\\> 4 cups or glasses \u002F day).\n* Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests.\n* Positive results for drugs of abuse tests.\n* No possibility of contact subject in case of emergency.\n* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.\n* Exclusion period of a previous study.\n* Administrative or legal supervision.\n* Subject who would receive more than 6'000 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.",true,"ALL","18 Years","65 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"PHASE1","The purpose of this study is to define and compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EYP651 at two dose levels and compare it with Vonafexor Acid PK and PD profile, the Part A.\n\nIn addition, Part B of the trial will assess the Drug-Drug Interactions (DDI) potential with the high dose of EYP651.",[106],"Healthy Adult Male and Female Volunteers",[108,109,110],"Drug-Drug Interactions","Pharmacokinetic","Pharmacodynamic","2026-02-25",{"date":113,"type":114},"2026-02-27","ACTUAL",{"date":116,"type":114},"2025-10-28",{"date":118,"type":100},"2026-10-28",{"name":5,"class":6},1]