A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
Status:
Completed
Trial end date:
2021-04-28
Target enrollment:
Participant gender:
Summary
People with type 2 diabetes have too much sugar in their blood and need treatment to control
their sugar level. The 3 study compounds in this study are similar to an approved
antidiabetic medicine that helps to lower blood sugar levels in people with type 2 diabetes.
This approved antidiabetic medicine is generally safe and well tolerated. The study compounds
are expected to have the same antidiabetic effect as the approved medicine. The purpose of
this study is to investigate how quickly and to what extent each of the 3 study compounds are
broken down in the body (this is called pharmacokinetics). The dose of each study compound
will be very low (this is called a microdose), and will be labelled with a small amount of
carbon-14. This is radioactive, and it makes it possible to track the study compound in the
blood. The 3 study compounds in this study have not been given to humans before. The study
will be performed in up to 18 healthy male volunteers. The study will consist of 3 groups of
6 volunteers each. Each participant will receive only one dose of study medicine.