Investigation of safety, tolerability and pharmacokinetics of multiple doses of NNC0113‑6856 in healthy participants, including a subset of healthy Japanese participants
This research is looking at a new medicine called NNC0113-6856. It's being tested in healthy volunteers, which means people who don’t have any known health problems. We also want to include a group of healthy Japanese volunteers to see if there are any differences. The main goals are to check how safe the medicine is at different doses and how well people tolerate it (if they have side effects). We’re also interested in understanding how the body takes in and gets rid of the medicine. This is a very early stage of testing, often called a Phase 1 study, where we focus on safety before looking at whether the medicine can treat specific conditions like Type 2 diabetes.
At a glance
What is this study about?
This study is about a new investigational medicine called NNC0113-6856. In this early stage of research, we're giving it to healthy volunteers, meaning people who are generally well and don't have any major medical conditions. We're specifically interested in seeing how the medicine behaves in people without existing health problems. This helps us ensure it's safe before we give it to people who might be unwell.
The main things we want to find out are how safe the medicine is when people take it multiple times, and if there are any side effects or discomfort. We also want to understand how the body processes the medicine – how it gets absorbed, changed, and eventually leaves the body. This information is really important for developing new medicines responsibly.
Even though this medicine might eventually be used for conditions like Type 2 diabetes, that's not what this particular study is focusing on yet. We're purely looking at the basics of safety and how the body handles the medicine in healthy individuals. This is a crucial step before we can move on to testing if it works for specific illnesses. We're also including a group of healthy Japanese volunteers to see if biological differences might affect how the medicine works.
Key takeaways
- This is an early safety study of a new medicine.
- It's for healthy people, including those of Japanese background, aged 18 and over.
- The main goal is to check safety and how the body handles the medicine.
- It's not testing if the medicine treats Type 2 diabetes yet.
- Participation involves taking the medicine and regular health checks.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for healthy adults. You need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part if they are in good health.
Both men and women can participate in this study. The main requirement is that you are considered healthy overall. This typically means you don't have any long-term medical conditions and aren't taking regular medicines.
Since this is a health study, there will be checks to make sure you are suitable. These checks will include a physical examination, blood tests, and a review of your medical history to confirm you are in good health.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you generally healthy with no major medical conditions?
- Are you able to attend appointments regularly?
- Are you willing to potentially take a new, untried medicine?
- Are you a man or a woman?
What does participation involve?
If you decide to take part, you would receive multiple doses of the new medicine, NNC0113-6856, over a period of time. This would involve regular visits to a clinic or hospital for assessments. During these visits, doctors and nurses would check your health, take blood samples, and ask you about any side effects you might be experiencing. You would be carefully monitored throughout the study period.
The total duration of your participation, including follow-up appointments after you've finished taking the medicine, would be explained to you in detail before you agree to join. This study might involve an initial screening to ensure you meet all health criteria, followed by dosing periods and then follow-up checks. You will be told exactly how many visits are needed and how long each visit might last.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is a 'healthy participant'?
A 'healthy participant' is someone who doesn't have any significant medical conditions and is generally well, as determined by doctors through medical checks.
Why include Japanese participants?
Including Japanese participants helps researchers see if there are any differences in how the medicine works or is handled by the body in different ethnic groups.
Is this medicine trying to treat my Type 2 diabetes?
No, not in this study. This study is only checking the medicine's safety and how the body handles it in healthy people, not whether it treats Type 2 diabetes.
Will I know if I'm getting the real medicine?
In some studies, participants might not know if they're receiving the active medicine or a placebo (dummy medicine). The study team will explain the details of this to you.
Do I have to pay to join the study?
No, you will not have to pay to join the study. Sometimes, participants are also reimbursed for their time and travel.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.