- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817644
A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets
February 21, 2024 updated by: Novo Nordisk A/S
A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females
Participants in the study, will receive the study drug once daily for 10 days in tablet form for oral (by mouth) intake.
On day 1 to 5 the tablet will contain 3 mg semaglutide, and on day 6-10 the tablet will contain 7 mg semaglutide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78209
- ICON Early Phase Services, LLC
-
-
Utah
-
Millcreek, Utah, United States, 84124
- ICON-Salt Lake City
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy, female subjects who have given birth at least 3 months prior to screening and who breastfeed (breastfeeding is defined by feeding the baby milk produced by the mother. Using a breast pump to collect milk and subsequently feeding it to the baby by bottle, is also defined as breastfeeding ) their infant to an extent, where the majority of the infant's total energy intake is from breastfeeding and sufficient milk is produced to fulfil the trial requirements, as judged by the investigator.
- Agree to abstain from breastfeeding their infant from first dose of oral semaglutide to the "End of trial" visit (total of 47 days) to avoid potentially exposing their child to semaglutide and SNAC.
- The breastfed infant is able to feed from a bottle (expenses related to alternative infant nutrition during trial participation will be covered by Novo Nordisk) prior to screening.
- Age above or equal to 18 years at the time of agreement to take part.
- Body mass index (BMI) between 20.0 and 32.4 kg/m^2 (both inclusive).
Exclusion Criteria:
- Female who is pregnant or intends to become pregnant or is of child-bearing potential and not using an effective contraceptive method.
- Glycated haemoglobin (HbA1c) greater than or equal to 6.5 % (48 mmol/mol) at screening.
- Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
- History (as declared by the subject or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
- Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by the subject or reported in the medical records).
- Presence or history (as declared by the subject or reported in the medical records) of malignant neoplasm within 5 years prior to the day of screening (basal or squamous cell skin cancer, or any carcinoma in-situ is allowed).
- Presence or history (as declared by the subject or reported in the medical records) of pancreatitis (acute or chronic).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral semaglutide
All participants will receive oral semaglutide once daily for a total of 10 days: 3 mg for 5 days followed by 7 mg for 5 days.
|
Oral semaglutide once daily for a total of 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
ng*h/mL
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
Hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant semaglutide dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
mg/kg/day
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Relative daily infant semaglutide dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
ng/kg/day
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Relative daily infant SNAC dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC metabolite E494 dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC metabolite E506 dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC metabolite E1245 dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC metabolite E1246 dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Estimated daily infant SNAC metabolite E1247 dose
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
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)
Time Frame: From 0 to 24 hours after the 10th dosing (day 10)
|
hours
|
From 0 to 24 hours after the 10th dosing (day 10)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2021
Primary Completion (Actual)
May 26, 2023
Study Completion (Actual)
July 3, 2023
Study Registration Dates
First Submitted
March 23, 2021
First Submitted That Met QC Criteria
March 23, 2021
First Posted (Actual)
March 26, 2021
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 21, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9924-4669
- U1111-1253-4467 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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