[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100117202":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":25,"responsibleParty":39,"collaborators":41,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":24,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":24,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":65,"whyStopped":24,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"KEMRI-Wellcome Trust Collaborative Research Program","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Methotrexate","EXPERIMENTAL","Oral methotrexate 5mg once daily for 5 consecutive days",[13],"Drug: Methotrexate",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],[19],"Methotrexate Lerdele",[21],{"name":22,"affiliation":5,"role":23},"Alexis Nzila, Msc","PRINCIPAL_INVESTIGATOR",null,[26],{"facility":27,"status":24,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":24},"Kenya Medical Research Institute, Center for Clinical Research","Nairobi","Nairobi County","00200","Kenya","KE",{"type":34,"coordinates":35},"Point",[36,37],36.81667,-1.28333,{"lat":37,"lon":36},{"type":40,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[42],{"name":43,"class":6},"University of Oxford","100117202","phase-1-assessment-of-safety-and-pharmacokinetics-of-a-low-dose-of-methotrexate-in-healthy-adult-male-kenyan-volunteers-100117202",false,"NCT00791531","Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers","Phase 1 Assessment of Safety and Pharmacokinetics of a Low Dose of Methotrexate in Healthy Adult Male Kenyan Volunteers","Inclusion Criteria:\n\n* Males, Aged \\> 18 -\\\u003C 55years old; weighing 55-75 kg\n* Serum haemoglobin \\>10g\u002Fdl\n* HIV negative status\n* Written informed consent from the study subject.\n\nExclusion Criteria:\n\n* Severe underlying conditions such as malnutrition (W\u002FH \\\u003C70%), clinically suspected cardiac, renal, or hepatic diseases, suspected AIDS, or severe injury.\n* Presence of any concomitant illnesses such malaria, lower respiratory tract infections (LRTI), acute bloody or non-bloody diarrhoeas, or other as acute infections\n* History of treatment with antimalarial drugs within the last 2 weeks\n* History of treatment with aspirin or any non-steroidal-anti-inflammatory agent or trimethoprim and co-trimoxazole within the last 7 days.\n* Any ongoing medication.\n* Abnormal clinical chemistry or haematological finding\n* Alcohol\u002Fdrugs intake\n* Any other reason in the recruiting clinician's opinion that makes the individual unsuitable for taking part in a clinical trial.",true,"MALE","18 Years","55 Years",{"count":56,"type":57},25,"ACTUAL","INTERVENTIONAL",[60],"PHASE1","Previous investigations indicate that methotrexate, an old anticancer drug, could be used at low doses to treat malaria. This is a phase I evaluation to assess the safety and pharmacokinetic profile of this drug in healthy adult male Kenyan volunteers.",[63],"Malaria",[9,63],"COMPLETED","2012-04-23",{"date":68,"type":69},"2012-04-24","ESTIMATED",{"date":71,"type":24},"2009-03",{"date":73,"type":57},"2009-08",{"name":5,"class":6},1]