[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100154928":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":20,"responsibleParty":26,"collaborators":20,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":20,"eligibilityCriteria":34,"healthyVolunteers":35,"sex":36,"minAge":37,"maxAge":38,"enrollmentInfo":39,"targetDuration":20,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":48,"overallStatus":55,"whyStopped":20,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"Tibotec Pharmaceuticals, Ireland","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL","TMC649128 Escalated doses",[13],"Drug: TMC649128",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TMC649128","Escalated doses",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Tibotec Pharmaceuticals Clinical Trial","Tibotec Pharmaceutical Limited","STUDY_DIRECTOR",{"type":27,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100154928","phase-1-tmc649128hpc1001---first-in-human-trial-to-examine-safety-tolerability-and-pharmacokinetics-how-the-drug-is-absorbed-into-the-bloodstream-of-increasing-single-oral-doses-of-tmc649128-in-healthy-volunteers-100154928",false,"NCT01288677","TMC649128HPC1001 - First In-human Trial to Examine Safety, Tolerability, and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses of TMC649128 in Healthy Volunteers","Phase I, First In-human, Double-blind, Randomized, Placebo-controlled Trial to Examine the Safety, Tolerability, and Blood and Plasma Pharmacokinetics of Increasing Single Oral Doses of TMC649128","Inclusion Criteria:\n\n* Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram\n* Body Mass Index of 18.0 to 30.0 kg\u002Fm² and non-smoker for at least 3 months prior to selection\n* Women must be postmenopausal for at least 2 years and\u002For be surgically sterile.\n\nExclusion Criteria:\n\n* Infection with Hepatitis A, B or C virus\n* infection with the Human Immunodeficiency Virus (HIV)\n* History of, or any current medical condition which could impact the safety of the participant in the study\n* A positive urine drug test at screening\n* History of any drug allergy or clinically relevant skin disease\n* Participation in an investigational drug trial or received an investigational vaccine within 30 days prior to intake.",true,"ALL","18 Years","55 Years",{"count":40,"type":41},54,"ACTUAL","INTERVENTIONAL",[44],"PHASE1","The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of single oral doses of TMC649128 in healthy volunteers. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.",[47],"Healthy Volunteer",[49,50,17,51,52,53,54],"Healthy volunteer","TMC649128HPC1001","HCV","Hepatitis C","healthy volunteers","Phase I trial","COMPLETED","2013-03-19",{"date":58,"type":59},"2013-03-20","ESTIMATED",{"date":61,"type":20},"2011-01",{"date":63,"type":41},"2011-06",{"name":5,"class":6}]