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

NCT04676906 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-04-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency ( dept. 1452) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-26
Primary Completion
2021-04-28
Completion
2021-04-28

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04676906 on ClinicalTrials.gov