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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04817644
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Oral semaglutide	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Trial Investigating Semaglutide and SNAC Concentrations in Breastmilk Following Administration of Multiple Doses of Oral Semaglutide in Healthy, Lactating Females
• Actual Study Start Date: Sep 10, 2021
• Anticipated Primary Completion Date: Oct 20, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the semaglutide milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   nmol*h/L

2. Area under the salcaprozate sodium (SNAC) milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   ng*h/mL

Secondary Outcome Measures

1. Average semaglutide milk concentration during a dosing interval after the 10th dosing (Cavg,sema,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   nmol/L

2. Maximum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   nmol/L

3. Minimum semaglutide milk concentration during a dosing interval after the 10th dosing (Cmin,sema,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   nmol/L

4. Time to maximum semaglutide milk concentration during a dosing interval after the 10th dosing (tmax,sema,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   Hours

5. Estimated daily infant semaglutide dose [From 0 to 24 hours after the 10th dosing (day 10)]

   mg/kg/day

6. Relative daily infant semaglutide dose [From 0 to 24 hours after the 10th dosing (day 10)]

7. Average SNAC milk concentration during a dosing interval after the 10th dosing (Cavg,SNAC,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   ng/mL

8. Maximum SNAC milk concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   ng/mL

9. Minimum SNAC milk concentration during a dosing interval after the 10th dosing (Cmin,SNAC,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

   ng/mL

10. Time to maximum SNAC milk concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

11. Estimated daily infant SNAC dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

12. Relative daily infant SNAC dose [From 0 to 24 hours after the 10th dosing (day 10)]

13. Area under the SNAC metabolite E494 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

14. Average SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cavg,E494,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

15. Maximum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

16. Minimum SNAC metabolite E494 milk concentration during a dosing interval after the 10th dosing (Cmin,E494,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

17. Time to maximum SNAC metabolite E494 milk concentration after the 10th dosing (tmax,E494,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

18. Estimated daily infant SNAC metabolite E494 dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

19. Area under the SNAC metabolite E506 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

20. Average SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cavg,E506,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

21. Maximum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

22. Minimum SNAC metabolite E506 milk concentration during a dosing interval after the 10th dosing (Cmin,E506,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

23. Time to maximum SNAC metabolite E506 milk concentration after the 10th dosing (tmax,E506,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

24. Estimated daily infant SNAC metabolite E506 dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

25. Area under the SNAC metabolite E1245 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

26. Average SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cavg,E1245,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

27. Maximum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

28. Minimum SNAC metabolite E1245 milk concentration during a dosing interval after the 10th dosing (Cmin,E1245,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

29. Time to maximum SNAC metabolite E1245 milk concentration after the 10th dosing (tmax,E1245,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

30. Estimated daily infant SNAC metabolite E1245 dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

31. Area under the SNAC metabolite E1246 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

32. Average SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cavg,E1246,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

33. Maximum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

34. Minimum SNAC metabolite E1246 milk concentration during a dosing interval after the 10th dosing (Cmin,E1246,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

35. Time to maximum SNAC metabolite E1246 milk concentration in milk after the 10th dosing (tmax,E1246,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

36. Estimated daily infant SNAC metabolite E1246 dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

37. Area under the SNAC metabolite E1247 milk concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

38. Average SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cavg,E1247,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

39. Maximum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

40. Minimum SNAC metabolite E1247 milk concentration during a dosing interval after the 10th dosing (Cmin,E1247,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

41. Time to maximum SNAC metabolite E1247 milk concentration after the 10th dosing (tmax,E1247,D10,milk) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

42. Estimated daily infant SNAC metabolite E1247 dose [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/kg/day

43. Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,sema,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    nmol*h/L

44. Maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (Cmax,sema,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    nmol/L

45. Time to maximum semaglutide plasma concentration during a dosing interval after the 10th dosing (tmax,sema,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

46. Area under the SNAC plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,SNAC,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

47. Maximum SNAC plasma concentration during a dosing interval after the 10th dosing (Cmax,SNAC,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

48. Time to maximum SNAC plasma concentration during a dosing interval after the 10th dosing (tmax,SNAC,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

49. Area under the SNAC metabolite E494 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E494,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

50. Maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (Cmax,E494,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

51. Time to maximum SNAC metabolite E494 plasma concentration during a dosing interval after the 10th dosing (tmax,E494,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

52. Area under the SNAC metabolite E506 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E506,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

53. Maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (Cmax,E506,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

54. Time to maximum SNAC metabolite E506 plasma concentration during a dosing interval after the 10th dosing (tmax,E506,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

55. Area under the SNAC metabolite E1245 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1245,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

56. Maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1245,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

57. Time to maximum SNAC metabolite E1245 plasma concentration during a dosing interval after the 10th dosing (tmax,E1245,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

58. Area under the SNAC metabolite E1246 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1246,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

59. Maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1246,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

60. Time to maximum SNAC metabolite E1246 plasma concentration during a dosing interval after the 10th dosing (tmax,E1246,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

61. Area under the SNAC metabolite E1247 plasma concentration-time curve during a dosing interval after the 10th dosing (AUC0-24h,E1247,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng*h/mL

62. Maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (Cmax,E1247,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    ng/mL

63. Time to maximum SNAC metabolite E1247 plasma concentration during a dosing interval after the 10th dosing (tmax,E1247,D10,plasma) [From 0 to 24 hours after the 10th dosing (day 10)]

    hours

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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 signing informed consent.

• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT04817644
• Other Study ID Numbers: NN9924-4669; U1111-1253-4467
• First Posted: Mar 26, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Sep 16, 2021