NCT04109508

A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets

A Comparative Bioavailability Trial of Steady State Semaglutide Exposure With the Current Formulation (Semaglutide) and a New Formulation (Semaglutide C) of Oral Semaglutide in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested. Besides semaglutide, the current version of the tablet contains 300 mg SNAC and 3 helping agents, while the new version of the tablet contains 300 mg SNAC and only one helping agent. Both are for the treatment of diabetes. Currently, semaglutide is only prescribed as injections for the treatment of diabetes in some countries. Semaglutide cannot yet be prescribed as a tablet. The aim of this study is to find out if the dosage strength of the current formulation of semaglutide can be reduced in the new tablet formulation. For this purpose, it will be measured how much semaglutide is taken up in the body from the two (2) different tablet formulations each with three (3) different dosage strengths. Participants will get semaglutide in the current tablet formulation and in a new formulation - in which order they receive the two different formulations is decided by chance. Participants will get one tablet per day over 4 weeks in each of the 3 treatment periods (i.e. treatment for a total of 12 weeks). The tablets should be taken in the morning together with half a glass of water (120 mL), after an overnight fast of at least 6 hours (no food or drinks). Furthermore, water is not allowed from 2 hours before dosing. After dosing participants must wait 30 minutes before they may eat or drink. At home, they must take their breakfast 30-45 minutes after dosing.

Conditions

• Healthy Volunteers
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Oral semaglutide	Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks

Timeline

• Start date: 2019-10-02
• Primary completion: 2020-12-24
• Completion: 2021-01-27
• First posted: 2019-09-30
• Last updated: 2021-02-09

Locations

1 site across 1 country: Germany