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

NCT04676906 | Completed Phase 1

• 3 other identifiers: NN9520-47092020-003449-13U1111-1255-1447
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  hours

  From time of first dosing (Day 1) until Day 64

Study Arms (3)

Study compound 1

EXPERIMENTAL

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

Drug: NNC0113-6861

Study compound 2

EXPERIMENTAL

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

Drug: NNC0113-6860

Study compound 3

EXPERIMENTAL

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

Drug: NNC0113-6891

Interventions

NNC0113-6861 DRUG

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

Study compound 1

NNC0113-6860 DRUG

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

Study compound 2

NNC0113-6891 DRUG

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

Study compound 3

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency ( dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 21, 2020
• Study Start: November 26, 2020
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)