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

What this study is testing ClinicalTrials.gov NCT05996874 ↗

Description as written by the study sponsor.

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.

Treatments tested

• 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.