NCT04676906

A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds

A Phase 0, Open-label, Candidate Selection Study Assessing the Pharmacokinetics of 3 Drug Candidates After a Single Intravenous, 14C-labelled Microdose in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	NNC0113-6861	Study compound 1 - Each participant will receive a single intravenous (i.v) dose of \[14C\]-NNC0113-6861
DRUG	NNC0113-6860	Study compound 2 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6860
DRUG	NNC0113-6891	Study compound 3 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6891

Timeline

• Start date: 2020-11-26
• Primary completion: 2021-04-28
• Completion: 2021-04-28
• First posted: 2020-12-21
• Last updated: 2023-04-27

Locations

1 site across 1 country: Netherlands