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Clinical Trial Details

Trial ID: L2706
Source ID: NCT04817644
Associated Drug: Oral Semaglutide
Title: A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Oral semaglutide
Outcome Measures: Primary: Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk), nmol\*h/L, From 0 to 24 hours after the 10th dosing (day 10)|Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10) | Secondary: Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk), nmol/L, From 0 to 24 hours after the 10th dosing (day 10)|Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk), nmol/L, From 0 to 24 hours after the 10th dosing (day 10)|Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk), nmol/L, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk), Hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant semaglutide dose, mg/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Relative daily infant semaglutide dose, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Relative daily infant SNAC dose, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC metabolite E494 dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC metabolite E506 dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC metabolite E1245 dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC metabolite E1246 dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1247 milk concentration after the 10th dosing (tmax,E1247,D10,milk), hours, From 0 to 24 hours after the 10th dosing (day 10)|Estimated daily infant SNAC metabolite E1247 dose, ng/kg/day, From 0 to 24 hours after the 10th dosing (day 10)|Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,plasma), nmol\*h/L, From 0 to 24 hours after the 10th dosing (day 10)|Maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,plasma), nmol/L, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (tmax,sema,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC plasma concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC plasma concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E494 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (tmax,E494,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E506 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (tmax,E506,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (tmax,E1245,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1246 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (tmax,E1246,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)|Area under the SNAC metabolite E1247 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,plasma), ng\*h/mL, From 0 to 24 hours after the 10th dosing (day 10)|Maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,plasma), ng/mL, From 0 to 24 hours after the 10th dosing (day 10)|Time to maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (tmax,E1247,D10,plasma), hours, From 0 to 24 hours after the 10th dosing (day 10)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-09-10
Completion Date: 2023-07-03
Results First Posted:
Last Update Posted: 2025-03-11
Locations: ICON Early Phase Services, LLC, San Antonio, Texas, 78209, United States|ICON-Salt Lake City, Salt Lake City, Utah, 84124, United States
URL: https://clinicaltrials.gov/show/NCT04817644