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

NCT ID: NCT04676906

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-26
• Study Completion Date: 2021-04-28

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 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study compound 1

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

Group Type: EXPERIMENTAL

NNC0113-6861

Intervention Type: DRUG

Study compound 1 - Each participant will receive a single intravenous (i.v) dose of \[14C\]-NNC0113-6861

Study compound 2

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

Group Type: EXPERIMENTAL

NNC0113-6860

Intervention Type: DRUG

Study compound 2 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6860

Study compound 3

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

Group Type: EXPERIMENTAL

NNC0113-6891

Intervention Type: DRUG

Study compound 3 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6891

Interventions

NNC0113-6861

Study compound 1 - Each participant will receive a single intravenous (i.v) dose of \[14C\]-NNC0113-6861

Intervention Type: DRUG

NNC0113-6860

Study compound 2 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6860

Intervention Type: DRUG

NNC0113-6891

Study compound 3 - Each participant will receive a single i.v dose of \[14C\]-NNC0113-6891

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 54 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency ( dept. 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

2020-003449-13

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1255-1447

Identifier Type: OTHER

Identifier Source: secondary_id

NN9520-4709

Identifier Type: -

Identifier Source: org_study_id