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NCT Number: NCT04676906

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

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.

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Key information

Conditions

Healthy Volunteers Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–54 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0113-6861

Drug

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

NNC0113-6860

Drug

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

NNC0113-6891

Drug

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

Primary outcomes

  1. 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

    Time frame: From time of first dosing (Day 1) until Day 64

    hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2020
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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