NCT03638778

Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

A Trial Comparing Exposure of Semaglutide When Dosing New Formulations of Oral Semaglutide to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide 3 mg	Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.
DRUG	Semaglutide 7 mg	Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
DRUG	Semaglutide B 3 mg	Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.
DRUG	Semaglutide B 7 mg	Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
DRUG	Semaglutide C 3 mg	Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.
DRUG	Semaglutide C 7 mg	Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
DRUG	Semaglutide D 3 mg	Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.
DRUG	Semaglutide D 7 mg	Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.

Timeline

• Start date: 2018-08-17
• Primary completion: 2018-12-05
• Completion: 2018-12-05
• First posted: 2018-08-20
• Last updated: 2019-11-14

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study