[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304019":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":34,"locations":48,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":34,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":34,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":34,"overallStatus":87,"whyStopped":34,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,16,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Sequence 1: ABC1D1","EXPERIMENTAL","Single dose of reference capsule GDC-0134 (Treatment A) during Period 1. Single dose of prototype capsule GDC-0134 (Treatment B) during Period 2. Single dose of GDC-0134 prototype capsule administered as GDC-0134-in-applesauce preparation under fasting conditions (Treatment C1) during Period 3. Single dose of GDC-0134 prototype capsule administered under fasting conditions in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D1) during Period 4. The washout period between doses will be a minimum of 21 days.",[13,14,15],"Drug: Reference capsule GDC-0134","Drug: Prototype capsule GDC-0134","Drug: rabeprazole",{"label":17,"type":10,"description":18,"interventionNames":19},"Treatment Sequence 2: ABC2D2","Single dose of reference capsule GDC-0134 (Treatment A) during Period 1. Single dose of prototype capsule GDC-0134 (Treatment B) during Period 2. Single dose of GDC-0134 prototype capsule administered after a high-fat meal (Treatment C2) during Period 3. Single dose of GDC-0134 prototype capsule administered after a high-fat meal in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D2) during Period 4. The washout period between doses will be a minimum of 21 days.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Treatment Sequence 3: BAC1D1","Single dose of prototype capsule GDC-0134 (Treatment B) during Period 1. Single dose of reference capsule GDC-0134 (Treatment A) during Period 2. Single dose of GDC-0134 prototype capsule administered as GDC-0134-in-applesauce preparation under fasting conditions (Treatment C1) during Period 3. Single dose of GDC-0134 prototype capsule administered under fasting conditions in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D1) during Period 4. The washout period between doses will be a minimum of 21 days.",[13,14,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Treatment Sequence 4: BAC2D2","Single dose of prototype capsule GDC-0134 (Treatment B) during Period 1. Single dose of reference capsule GDC-0134 (Treatment A) during Period 2. Single dose of GDC-0134 prototype capsule administered after a high-fat meal (Treatment C2) during Period 3. Single dose of GDC-0134 prototype capsule administered after a high-fat meal in combination with 20 mg rabeprazole, and following prior administration of rabeprazole once daily for 3 days (Treatment D2) during Period 4. The washout period between doses will be a minimum of 21 days.",[13,14,15],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Reference capsule GDC-0134","Oral administration of a single dose of 200 milligrams (mg) GDC-0134 reference capsule administered as two 100 mg capsules.",[9,17,21,25],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Prototype capsule GDC-0134","Oral administration of a single dose of 200 mg GDC-0134 prototype capsule administered as one 200 mg capsule.",[9,17,21,25],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"rabeprazole","Oral administration of 20 mg rabeprazole once daily on Days -3, -2 and -1 as well as on Day 1 two hours prior to each administration of GDC-0134 during Period 4.",[9,17,21,25],[44],{"name":45,"affiliation":46,"role":47},"Clinical Trials","Hoffmann-La Roche","STUDY_DIRECTOR",[49],{"facility":50,"status":34,"city":51,"state":34,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":34},"Quotient Clinical Ltd, Clinical Research Unit","Nottingham","NG11 6JS","United Kingdom","UK",{"type":56,"coordinates":57},"Point",[58,59],-1.15047,52.9536,{"lat":59,"lon":58},{"type":62,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[64],{"name":65,"class":66},"Quotient Clinical","OTHER","100304019","phase-1-bioavailability-of-gdc-0134-and-the-effect-of-food-and-proton-pump-inhibitor-on-pharmacokinetics-of-gdc-0134-in-healthy-female-participants-100304019",false,"NCT03237741","Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants","A Phase I Open-Label Study to Determine the Relative Bioavailability of GDC-0134 and to Investigate the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Subjects of Non-childbearing Potential","Inclusion Criteria:\n\n* Healthy female participants between 30 and 65 years of age, inclusive;\n* Within body mass index range 18.0 to 35.0 kilograms per square meter (kg\u002Fm\\^2), inclusive;\n* Female participants will be of non-childbearing potential;\n* In good health, determined by no clinically significant findings from medical history, 12-lead echocardiogram (ECG), and vital signs;\n* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the investigator;\n* Normal ophthalmology assessment.\n\nExclusion Criteria:\n\n* Males and females of childbearing potential;\n* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the investigator;\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator;\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs;\n* History of GI bleeding or GI ulcers;\n* Any personal or family history of bleeding disorders, and any personal use of drugs known to affect blood clotting within 30 days of dosing;\n* Any acute or chronic medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the subject's safe participation in and completion of the study.",true,"FEMALE","30 Years","65 Years",{"count":79,"type":80},18,"ACTUAL","INTERVENTIONAL",[83],"PHASE1","This study will evaluate the pharmacokinetics and safety of GDC-0134 in healthy female volunteers of non-childbearing potential. The first part of the study will compare the bioavailability of a prototype capsule of GDC-0134 relative to an existing GDC-0134 reference capsule (Periods 1 and 2). The second part of the study will assess the effect of GDC-0134-in-applesauce preparation under fasting conditions, the effect of low and high fat foods as well as the effect of elevated stomach pH via pre-treatment with rabeprazole, a proton pump inhibitor (PPI), under fasted and high-fat meal conditions (Periods 3 and 4).",[86],"Amyotrophic Lateral Sclerosis","COMPLETED","2024-02-29",{"date":90,"type":80},"2024-03-01",{"date":92,"type":80},"2017-08-07",{"date":94,"type":80},"2017-12-14",{"name":5,"class":6},1]