Healthy VolunteersPhase 1NCT04676906
A Study Investigating the Distribution and Metabolism of Three 14C-labeled Radioactive Study Compounds
A Phase 1 study testing NNC0113-6861, NNC0113-6860 and NNC0113-6891 in people with Healthy Volunteers and Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Type 2 Diabetes
- What is being tested?
- NNC0113-6861, NNC0113-6860 and NNC0113-6891
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2020to 28 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- NNC0113-6861, NNC0113-6860, NNC0113-6891
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0113-6861Drug
Study compound 1 - Each participant will receive a single intravenous (i.v) dose of [14C]-NNC0113-6861
NNC0113-6860Drug
Study compound 2 - Each participant will receive a single i.v dose of [14C]-NNC0113-6860
NNC0113-6891Drug
Study compound 3 - Each participant will receive a single i.v dose of [14C]-NNC0113-6891
| Study group | Role | What they receive |
|---|---|---|
| Study compound 1 | Experimental | Up to 6 volunteers will receive one dose of study compound 1 Receives: Drug: NNC0113-6861 |
| Study compound 2 | Experimental | Up to 6 volunteers will receive one dose of study compound 2 Receives: Drug: NNC0113-6860 |
| Study compound 3 | Experimental | Up to 6 volunteers will receive one dose of study compound 3 Receives: Drug: NNC0113-6891 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From time of first dosing (Day 1) until Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start26 Nov 2020
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency ( dept. 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04676906
- Sponsor's protocol ID
- NN9520-4709
- Other IDs
- 2020-003449-13, U1111-1255-1447
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2020
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04676906
- Acronym / sponsor ID
- NN9520-4709
- Conditions
- Healthy Volunteers, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study compound 1 | Experimental | Drug: NNC0113-6861Up to 6 volunteers will receive one dose of study compound 1 |
| Study compound 2 | Experimental | Drug: NNC0113-6860Up to 6 volunteers will receive one dose of study compound 2 |
| Study compound 3 | Experimental | Drug: NNC0113-6891Up to 6 volunteers will receive one dose of study compound 3 |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 .
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0113-6861Study compound 1 - Each participant will receive a single intravenous (i.v) dose of [14C]-NNC0113-6861 | Drug | Study compound 1 |
| NNC0113-6860Study compound 2 - Each participant will receive a single i.v dose of [14C]-NNC0113-6860 | Drug | Study compound 2 |
| NNC0113-6891Study compound 3 - Each participant will receive a single i.v dose of [14C]-NNC0113-6891 | Drug | Study compound 3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency ( dept. 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0113-6861, NNC0113-6860 and NNC0113-6891 in people with Healthy Volunteers and Type 2 Diabetes, run by Novo Nordisk A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From time of first dosing (Day 1) until Day 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.