A Research Study to See How Much Semaglutide and SNAC is in the Milk of Healthy, Breastfeeding Women Taking Semaglutide Tablets

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04817644
• Other study ID #: NN9924-4669
• Secondary ID: U1111-1253-4467
• Status: Completed
• Phase: Phase 1
• Start date: September 10, 2021
• Est. completion date: July 3, 2023

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 3, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Oral semaglutide
Oral semaglutide once daily for a total of 10 days

Locations

Country	Name	City	State
United States	ICON-Salt Lake City	Millcreek	Utah
United States	ICON Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Primary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant semaglutide dose	mg/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	Relative daily infant semaglutide dose		From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	Relative daily infant SNAC dose		From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC metabolite E494 dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC metabolite E506 dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC metabolite E1245 dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC metabolite E1246 dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Estimated daily infant SNAC metabolite E1247 dose	ng/kg/day	From 0 to 24 hours after the 10th dosing (day 10)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)