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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT04676906

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers Type 2 Diabetes	Drug: NNC0113-6861 Drug: NNC0113-6860 Drug: NNC0113-6891	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Nov 26, 2020

Actual Primary Completion Date :

Apr 28, 2021

Actual Study Completion Date :

Apr 28, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 [From time of first dosing (Day 1) until Day 64]
hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 54 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT04676906

Other Study ID Numbers:

NN9520-4709
2020-003449-13
U1111-1255-1447

First Posted:

Dec 21, 2020

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 29, 2022