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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Novo Nordisk A/S
Study ID
NCT04817644
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 10, 2021
Status verified
Mar 2025
Primary completion
May 26, 2023
Completion
Jul 3, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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) ]

Locations (2)

FacilityCityStateZIPSite coordinators
ICON Early Phase Services, LLCSan AntonioTexas78209-
ICON-Salt Lake CitySalt Lake CityUtah84124-

Find similar trials in San Antonio, TX

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By specialty
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By research site
ICON Early Phase Services, LLC· San Antonio, TXICON-Salt Lake City· Salt Lake City, UT

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