Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A research study looking at how the compound NNC0194-0499 works with birth control pills in women not able to bear children.

This research study is investigating a new medicine called NNC0194-0499. The main goal is to understand how this new compound interacts with birth control pills in the body. It's a very early-stage study, meaning it’s the first time this medicine is being given to people. We are looking for healthy women who have passed childbearing age (meaning they cannot get pregnant). This type of study helps us learn how the medicine behaves, how it's absorbed, and how it might affect other common medications like the pill before it can be studied in larger groups of people who might benefit from it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novo Nordisk A/S

Enrolment target

Start

17 Jul 2023

Healthy volunteers (Non-alcoholic steatohepatitis (NASH))

What is this study about?

Imagine you're trying a new recipe, and you want to see how one ingredient mixes with another common one. That's a bit like what this research study is doing, but with medicines. We're looking at a new compound, NNC0194-0499, and how it works alongside birth control pills in the human body. This is a very early study, often called 'Phase I'. This means it's one of the first times this new compound is being given to people, and the main aim is to understand basic things like how it’s absorbed, how long it stays in the body, and what happens when it's taken with birth control pills.

Even though the medicine is being studied in women past childbearing age, understanding its interaction with birth control pills is important. This helps us learn early on if there are any effects on how birth control pills work, which is crucial information for any future uses of NNC0194-0499 in women of childbearing age.

By taking part, you'd be helping scientists gain important knowledge about this new medicine. This information is a vital step in deciding if it's safe and effective enough to be studied further in the future for conditions it might be designed to treat.

Key takeaways

This study investigates a new medicine (NNC0194-0499) and its interaction with birth control pills.
It's an early-stage study, focusing on how the new medicine works in the body.
Healthy women who can no longer have children are invited to participate.
Participants will continue taking their regular birth control pills.
Your involvement could help advance medical research and understanding of this new compound.

Who may be eligible?

To join this study, we are looking for women who are healthy overall. You need to be at least 18 years old or older. A key requirement is that you must no longer be able to have children. This is an important safety measure for this particular research.

Being 'healthy' for this study means you generally feel well and don't have major ongoing health problems. While the original information does mention 'Non-alcoholic steatohepatitis (NASH)', for this specific study, we understand we are looking for volunteers who are healthy and do not have significant liver disease.

Before you can join, the study team will do a health check-up to make sure you fit all the necessary requirements and it's safe for you to take part.

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 a woman?
Are you 18 years old or older?
Are you no longer able to become pregnant (e.g., past menopause, hysterectomy)?
Do you generally consider yourself to be in good health?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new compound NNC0194-0499 and your usual birth control pills (if applicable). This is a 'Human Pharmacology' study, which means it focuses on understanding how the body handles the medicine. This usually involves regular visits to the study clinic, where you might have blood samples taken to measure the medicine levels, and possibly other tests like blood pressure or heart rate checks.

The study team will explain the exact schedule of visits and tests. You would be closely monitored throughout your time in the study. You'd also keep a diary or record certain details about how you are feeling. The total duration of your involvement, including any follow-up after you stop taking the medicine, will be clearly explained before you agree to participate.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of joining this study is contributing to medical knowledge that could help future patients. You would also receive careful medical monitoring during your participation. As for risks, because this is an early-stage study, all possible side effects of NNC0194-0499 might not be fully known. You could experience side effects from the study medication, though the research team will do everything they can to minimise these and will explain any known risks fully. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What does 'not able to bear children' mean for this study?

It means you are past menopause, have had a hysterectomy (womb removed), or have had both ovaries removed, meaning you cannot get pregnant naturally.

What is NNC0194-0499?

It's a new experimental medicine that is being tested for the very first time in humans. Its purpose is being investigated.

Will I stop taking my usual birth control pills?

No, you will continue taking your birth control pills as normal while also taking the study medication. The study wants to see how they work together.

Is this medicine for Non-alcoholic steatohepatitis (NASH)?

This early study is looking for healthy volunteers to understand the medicine's basic behaviour, not for treating NASH at this stage. It's a general safety and interaction study.

Do I have to pay to join the study?

No, you will not have to pay to take part in the study. All study-related medication and procedures will be provided at no cost to you.