A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants

Sponsor
Novo Nordisk A/S
Study ID
NCT05996874
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide — DRUG
    Participants will receive Dose 1 oral semaglutide D for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days.

Study Details

In this study, a known medicine called 'semaglutide' will be tested in a new tablet version. The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration. Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the treatment of type 2 diabetes. Participants will get a daily treatment with dose 1 new oral semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new oral semaglutide tablet. Participants will get one tablet each day for 10 days. The tablet should be taken in the morning on an empty stomach with either 50 milliliter (mL) or 120mL water, after an overnight fast of at least 6 hours (no food or drinks). Water is not allowed from 2 hours before dosing. A predefined breakfast will be served either 30, 60 or 120 minutes after taking tablet, depending on the treatment received. Breakfast will need to be eaten within 30 minutes. Which treatment participants will get is decided by chance. The study will last for about 11 weeks. This will include a screening period (up to 28 days), a treatment period (10 days) and a follow-up visit (at least 5 weeks after the last dose). Participants should not take any prescription or non-prescription medicines or herbal products (including St John's wort) within 14 days prior to the screening visit and until the follow-up visit, except for routine vitamins, medicines applied on the skin and occasional use of paracetamol (a mild pain killer). No oral medication can be taken from 2 hours before and, depending on the group participants are in, until 30, 60 or 120 minutes after each dosing with semaglutide.

Key Dates

Start date
Aug 12, 2023
Status verified
Sep 2025
Primary completion
Apr 18, 2024
Completion
Apr 18, 2024

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide: 50 mL water and 30 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 30 minutes post-dose fasting.
  • Experimental: Semaglutide: 120 mL water and 30 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by dose 2 of oral semaglutide D for another 5 days with 120 mL water and 30 minutes post-dose fasting.
  • Experimental: Semaglutide: 50 mL water and 60 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 60 minutes post-dose fasting.
  • Experimental: Semaglutide: 120 mL water and 60 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 60 minutes post-dose fasting.
  • Experimental: Semaglutide: 50 mL water and 120 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 120 minutes post-dose fasting.
  • Experimental: Semaglutide: 120 mL water and 120 minutes post-dose fasting
    Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 120 minutes post-dose fasting.

Primary Outcome Measure

AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing [ Time Frame: From 0 to 24 hours after dosing on day 10 ]

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