Status:
COMPLETED
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Type 2 Diabetes
Eligibility:
MALE
18-54 years
Phase:
PHASE1
Brief 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 tha...
Eligibility Criteria
Inclusion
- Healthy subject.
- Sex : Male.
- Age 18 to 54 years, inclusive, at the time of signing informed consent.
- Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive, at the time of signing informed consent .
Exclusion
- Known or suspected hypersensitivity to study product(s) or related products.
- Any disorder that in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
- Glycosylated haemoglobin (HbA1c) equal to or above 6.5% (48 mmol/mol) at screening.
- Personal or first-degree relative(s) history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma.
- Subjects with a history of malignant neoplasms within the past 5 years prior to screening.
- Presence or history of pancreatitis (acute or chronic; as declared by the subject or reported in the medical records).
- Participation in a study with a radiation burden of above 0.1 millisievert (mSv) in the period of 1 year prior to screening.
Key Trial Info
Start Date :
November 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04676906
Start Date
November 26 2020
End Date
April 28 2021
Last Update
April 27 2023
Active Locations (1)
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1
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NZ