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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04817644
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 10, 2021
Estimated Primary Completion Date : October 20, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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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
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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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: From 0 to 24 hours after the 10th dosing (day 10) ]
    Hours

  5. Estimated daily infant semaglutide dose [ Time Frame: From 0 to 24 hours after the 10th dosing (day 10) ]
    mg/kg/day

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

  11. Estimated daily infant SNAC dose [ Time Frame: From 0 to 24 hours after the 10th dosing (day 10) ]
    ng/kg/day

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

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

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

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

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

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04817644


Contacts
Layout table for location contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Texas
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04817644    
Other Study ID Numbers: NN9924-4669
U1111-1253-4467 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases