[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07669077":3,"trial-entities:NCT07669077":94,"trial-summary:NCT07669077":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":54,"eligibility_criteria":55,"std_ages":69,"locations":72,"central_contacts":82,"overall_officials":88,"references":92,"see_also_links":93},"NCT07669077","80202135EDI1011","A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women","A Phase 1, Open-Label, Lactation Study to Assess Concentrations of Nipocalimab in Breast Milk of Healthy Lactating Women","RECRUITING","2027-02-16","2026-07","2026-07-31","2026-06-23","Janssen Research & Development, LLC","INDUSTRY",false,"The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics \\[PK\\]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.",null,[19],"Healthy",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},8,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Nipocalimab","Nipocalimab will be administered as an intravenous (IV) infusion.",[34],"Healthy Lactating Participants",[36],"JNJ-80202135",{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Breast Milk Sampling","Breast milk sampling at pre-defined time points for 8 days.",[34],[43,47],{"measure":44,"description":45,"timeFrame":46},"Concentration of Nipocalimab in Breast Milk","The concentration of nipocalimab in breast milk over a 7-day sampling period (Day 1 up to Day 8) will be reported.","Up to Day 8",{"measure":48,"description":49,"timeFrame":50},"Area Under the Curve for Breast Milk Concentration","Area under the curve for breast milk concentration vs time curve from time 0 to 168 hours post-dose will be reported.","Up to 168 hours postdose",[],"FEMALE","18 Years",true,{"inclusion":56,"exclusion":62,"raw_text":68},[57,58,59,60,61],"Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening","Study participant must have good venous accessibility in both arms","Study participant must be between 5 weeks and 24 months post-partum, inclusive, on Day -1","Study participant must agree, when nipple cream is needed during the assessment phase, to use only lanolin nipple cream","Study participant must have well established lactation and must be exclusively breast-feeding her infant (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study",[63,64,65,66,67],"Study participant has history of breast implants, breast augmentation, or breast reduction surgery","Study participant currently has active or unresolved mastitis at screening or Day -1","Study participant currently has or had an active clinically significant infection within the last 6 weeks","Study participant has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol-specified assessments","Study participant has suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients","Inclusion criteria:\n\n* Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening\n* Study participant must have good venous accessibility in both arms\n* Study participant must be between 5 weeks and 24 months post-partum, inclusive, on Day -1\n* Study participant must agree, when nipple cream is needed during the assessment phase, to use only lanolin nipple cream\n* Study participant must have well established lactation and must be exclusively breast-feeding her infant (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n\nExclusion criteria:\n\n* Study participant has history of breast implants, breast augmentation, or breast reduction surgery\n* Study participant currently has active or unresolved mastitis at screening or Day -1\n* Study participant currently has or had an active clinically significant infection within the last 6 weeks\n* Study participant has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol-specified assessments\n* Study participant has suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients",[70,71],"ADULT","OLDER_ADULT",[73],{"facility":74,"status":8,"city":75,"state":76,"zip":77,"country":78,"geoPoint":79},"ICON","Salt Lake City","Utah","84124","United States",{"lat":80,"lon":81},40.76078,-111.89105,[83],{"name":84,"role":85,"phone":86,"email":87},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[89],{"name":90,"affiliation":13,"role":91},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[19],[],{"nct_id":4,"found":54,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study involving 8 healthy lactating women. It is not specified if it is randomized or blinded.","completed","Nipocalimab Concentrations in Breast Milk Study","This study is looking for healthy women who are breastfeeding to understand how much of the drug nipocalimab gets into breast milk. Researchers will give participants a single dose of nipocalimab through an IV (into the vein). They will then collect breast milk samples for up to 8 days to measure the drug levels. The main goal is to see the concentration of nipocalimab in breast milk and how it changes over time. This study is for women between 5 weeks and 24 months after giving birth. The study plans to enroll 8 participants, but its current status is unclear.","Breast milk concentrations will be measured for up to 8 days (168 hours) after the dose.",100,"You would receive a single intravenous (IV) infusion of nipocalimab and provide breast milk samples at specific times for up to 8 days.","Not stated in the trial record.",[31],"v2"]