[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100148370":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":75,"centralContacts":11,"locations":80,"responsibleParty":91,"collaborators":11,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":11,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":11,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Tibotec Pharmaceuticals, Ireland","INDUSTRY",[8,14,19,22,25,28,31,34,38,41],{"label":9,"type":10,"description":11,"interventionNames":12},"001","EXPERIMENTAL",null,[13],"Drug: TMC647055",{"label":15,"type":16,"description":11,"interventionNames":17},"008","PLACEBO_COMPARATOR",[18],"Drug: Placebo",{"label":20,"type":16,"description":11,"interventionNames":21},"002",[18],{"label":23,"type":10,"description":11,"interventionNames":24},"009",[13],{"label":26,"type":10,"description":11,"interventionNames":27},"003",[13],{"label":29,"type":16,"description":11,"interventionNames":30},"004",[18],{"label":32,"type":10,"description":11,"interventionNames":33},"005",[13],{"label":35,"type":10,"description":11,"interventionNames":36},"010",[37],"Drug: TMC435",{"label":39,"type":16,"description":11,"interventionNames":40},"006",[18],{"label":42,"type":10,"description":11,"interventionNames":43},"007",[13],[45,50,54,57,60,63,67,69,71,73],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"DRUG","TMC647055","One single dose as oral solution, doses from 100 mg up to a maximum of 3000 mg increasing in sessions I through VI.",[9],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":11},"Placebo","Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.",[15],{"type":46,"name":47,"description":55,"armGroupLabels":56,"otherNames":11},"Oral solution given in session XIII, treatment arm 1 during 10 days at a dose of 1000 mg every 12 hours.",[23],{"type":46,"name":47,"description":58,"armGroupLabels":59,"otherNames":11},"In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.",[32],{"type":46,"name":51,"description":61,"armGroupLabels":62,"otherNames":11},"One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII",[20],{"type":46,"name":64,"description":65,"armGroupLabels":66,"otherNames":11},"TMC435","Oral capsule given in session XIII, in treatment arm 1 during 10 days and in treatment arm 2 during 6 days at a dose of 150 mg once daily.",[35],{"type":46,"name":51,"description":61,"armGroupLabels":68,"otherNames":11},[29],{"type":46,"name":47,"description":61,"armGroupLabels":70,"otherNames":11},[26],{"type":46,"name":51,"description":58,"armGroupLabels":72,"otherNames":11},[39],{"type":46,"name":47,"description":52,"armGroupLabels":74,"otherNames":11},[42],[76],{"name":77,"affiliation":78,"role":79},"Tibotec Pharmaceuticals Clinical Trial","Tibotec Pharmaceutical Limited","STUDY_DIRECTOR",[81],{"facility":11,"status":11,"city":82,"state":11,"zip":11,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":11},"Antwerp","Belgium","BE",{"type":86,"coordinates":87},"Point",[88,89],4.40026,51.22047,{"lat":89,"lon":88},{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100148370","phase-1-tmc647055hpc1001---first-in-human-trial-to-examine-safety-tolerability-and-pharmacokinetics-how-the-drug-is-absorbed-into-the-bloodstream-of-increasing-single-oral-doses-and-of-increasing-repeated-oral-doses-of-tmc647055-in-healthy-volunteers-and-in-hepatitis-c-virus-infected-patients-100148370",false,"NCT01202825","TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients","Phase I, First-in-human Trial in Healthy Volunteers to Examine Increasing Single and Repeated Oral Doses of TMC647055, Followed by a Repeated-dose Part in Chronic HCV-genotype 1 Infected Patients to Examine TMC647055 Given Alone or in Combination With TMC435","Inclusion Criteria:\n\n* Healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg\u002Fm2, extremes included and be non-smoking for at least 3 months prior to selection\n* Chronic hepatitis-C infected patients should have documented chronic genotype 1a or 1b HCV infection, otherwise no clinically relevant currently active disease and a BMI of 18.0 to 35.0 kg\u002Fm2, extremes included\n* Women must be postmenopausal for at least 2 years, and\u002For be surgically sterile.\n\nExclusion Criteria:\n\n* All participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs\n* Use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-C infected patients products that are not CYP3A4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration\n* Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements\n* History or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and\u002For compliance with the trial procedures\n* Participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of TMC647055 or placebo.",true,"ALL","18 Years","65 Years",{"count":105,"type":106},72,"ACTUAL","INTERVENTIONAL",[109],"PHASE1","The purpose of this study is to assess the safety and tolerability of TMC647055 both after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days, as well as to assess the pharmacokinetics of TMC647055 after increasing single oral doses from 100 mg up to maximum 3000 mg in fed conditions, and after multiple oral doses in fed conditions at increasing dose levels administered for 6 days and to assess the effect of food on a single oral dose of TMC647055 at one dose level, all in healthy participants. In addition, the safety, tolerability, pharmacokinetics and the antiviral activity of TMC647055 will be determined after 6 days of consecutive dosing and of TMC647055 and TMC435 after 10 days of co-administration in chronic hepatitis C virus infected patients. Pharmacokinetics means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body. TMC647055 is being investigated for the treatment of chronic hepatitis C infection.",[112],"Hepatitis C",[114,115,47,116,112,117,64],"HCV genotype 1 infected patients","TMC647055HPC1001","HPC","Healthy volunteers","COMPLETED","2013-03-01",{"date":121,"type":122},"2013-03-04","ESTIMATED",{"date":124,"type":11},"2010-04",{"date":126,"type":106},"2011-11",{"name":5,"class":6},1]