Clinical trial NCT04676906: A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From time of first dosing (Day 1) until Day 64
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency ( dept. 1452)
role: STUDY_DIRECTOR
References: