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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers, Type 2 Diabetes

Intervention / Treatment
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* Drug: NNC0113-6861
* Drug: NNC0113-6860
* Drug: NNC0113-6891


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study compound 1<br>Up to 6 volunteers will receive one dose of study compound 1 | Drug: NNC0113-6861<br>* Study compound 1 - Each participant will receive a single intravenous (i.v) dose of [14C]-NNC0113-6861<br>|
| Experimental: Study compound 2<br>Up to 6 volunteers will receive one dose of study compound 2 | Drug: NNC0113-6860<br>* Study compound 2 - Each participant will receive a single i.v dose of [14C]-NNC0113-6860<br>|
| Experimental: Study compound 3<br>Up to 6 volunteers will receive one dose of study compound 3 | Drug: NNC0113-6891<br>* Study compound 3 - Each participant will receive a single i.v dose of [14C]-NNC0113-6891<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The apparent elimination half-life of each of the 3 study compounds and their active metabolite after a single iv dose of each of the 3 study compounds | hours | From time of first dosing (Day 1) until Day 64 |