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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Healthy Volunteers
• Intervention / Treatment: Drug: NNC0113-6861; Drug: NNC0113-6860; Drug: NNC0113-6891

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency ( dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NN9520-4709; 2020-003449-13 (Registry Identifier: European Medicines Agency (EudraCT)); U1111-1255-1447 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No