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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Type 2 Diabetes

Treatments: Drug: NNC0113-6861; Drug: NNC0113-6891; Drug: NNC0113-6860

Study type: Interventional

Funder types: Industry

Identifiers

NCT04676906

2020-003449-13 (Registry Identifier)

NN9520-4709

U1111-1255-1447 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 54 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Study compound 1

Experimental group

Description:

Up to 6 volunteers will receive one dose of study compound 1

Treatment:

Drug: NNC0113-6861

Study compound 2

Experimental group

Description:

Up to 6 volunteers will receive one dose of study compound 2

Treatment:

Drug: NNC0113-6860

Study compound 3

Experimental group

Description:

Up to 6 volunteers will receive one dose of study compound 3

Treatment:

Drug: NNC0113-6891