[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458417":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":36,"centralContacts":36,"locations":37,"responsibleParty":51,"collaborators":36,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":36,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":36,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":80,"whyStopped":36,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"PMV Pharmaceuticals, Inc","INDUSTRY",[8,14,18,22,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 Sequence A","EXPERIMENTAL","Period 1 will be fed, then washout, then Period 2 will be fasted.",[13],"Drug: PC14586",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 1 Sequence B","Period 1 will be fasted, then washout, then Period 2 will be fed.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part 2 Sequence C","Period 1 will be fed, then washout, then Period 2 will be fasted. A different dose of PC14586 will be tested.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Part 2 Sequence D","Period 1 will be fasted, then washout, then Period 2 will be fed. A different dose of PC14586 will be tested.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Part 2 Japanese Cohort","6 Japanese participants will be administered a single dose of PC14586.",[13],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","PC14586","An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).",[9,15,27,19,23],null,[38],{"facility":39,"status":36,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":36},"Parexel Early Phase Clinical Unit - Los Angeles","Glendale","California","91206","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.25508,34.14251,{"lat":49,"lon":48},{"type":52,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100458417","phase-1-effect-of-food-on-pc14586-in-healthy-volunteers-and-the-pk-of-pc14586-in-healthy-japanese-volunteers-100458417",false,"NCT05249348","Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers","A Phase 1 Open-label, Cross-over Study to Assess the Effects of Food on PC14586 Pharmacokinetics in Healthy Volunteers and to Assess PC14586 Pharmacokinetics in Healthy Japanese Volunteers Living in the US","Inclusion Criteria:\n\n* Healthy, non-smoking male and female Caucasian\u002F non-Asian or Japanese human volunteers\n* 18 to 55 years of age\n* Able to swallow tablets.\n\nInclusion criteria for Japanese participants only:\n\n* Japanese and born in Japan (1st generation)\n* The parents and grandparents of the participant are ethnically Japanese and born in Japan\n* Has undergone no significant change in lifestyle since leaving Japan\n* Has lived \\\u003C 10 years outside of Japan\n\nExclusion Criteria:\n\n* Clinically significant medical history as determined by the PI.\n* Any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.\n* A p53 Y220C mutation.\n* Blood pressure \\>140 mm systolic or \\>90 diastolic.\n* Smoked or used other nicotine-containing products during the previous 3 months.\n* History of alcohol and\u002For illicit drug abuse within the previous 5 years.\n* Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV).\n* Positive blood test for ethanol.\n* Positive urine drug test.\n* Pregnancy or breastfeeding.\n* Unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site.\n* Has donated blood within 2 months prior to admission.\n* Has used over-the-counter (OTC) medications (including vitamins), prescription medications or herbal remedies from 14 days prior to admission.\n* Has used an investigational drug within 30 days prior to Screening.",true,"ALL","18 Years","55 Years",{"count":65,"type":66},34,"ACTUAL","INTERVENTIONAL",[69],"PHASE1","This is a 2-part Phase 1 cross-over study to assess the effects of food on the pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a clinically relevant dose in Japanese participants will also be studied.",[72],"Healthy Volunteers",[74,33,75,76,77,78,79],"Y220C","PMV Pharma","PMV","food effect","Pharmacokinetics","Japanese","COMPLETED","2024-11-11",{"date":83,"type":66},"2024-11-13",{"date":85,"type":66},"2021-12-20",{"date":87,"type":66},"2022-06-09",{"name":5,"class":6},1]