A Phase 1, Open-label, Randomized, Crossover Study to Assess the Effect of Different Types of Co-administered Oral Liquids on the Relative Oral Bioavailability of a JNJ 77242113 Tablet Formulation in Healthy Participants.
This research is an early-stage study, called Phase 1, that aims to understand how our bodies absorb a new tablet called JNJ 77242113. This tablet is being developed to treat inflammatory conditions. We want to find out if drinking different types of liquids, like water or juice, at the same time as taking the tablet changes how much of the medicine gets into the bloodstream. Healthy adult volunteers will take the tablet multiple times with different drinks, allowing researchers to compare the results. This helps us learn the best way to take the medicine for future patients. This study is for healthy people and does not involve giving treatment for any illness.
At a glance
What is this study about?
Imagine you're trying a new recipe, and you want to know if adding different ingredients changes how it tastes. In a similar way, this study is about understanding how a new medicine works in the body, especially when taken with different drinks.
The medicine, called JNJ 77242113, is in tablet form and is being developed for conditions where the body's immune system causes inflammation. Before this medicine can be given to patients, researchers need to fully understand how it behaves. One important piece of information is its 'bioavailability' – this simply means how much of the medicine actually gets into your bloodstream and becomes available to work in your body. We want to see if taking the tablet with different types of liquids (like water, juice, or other common drinks) changes how much medicine the body absorbs.
This study is an early step in developing new medicines. It's called a 'Phase 1' study, which means it focuses on safety and understanding how the medicine moves through the body, rather than treating an illness. The participants in this study are healthy volunteers. By comparing how the medicine is absorbed when taken with various drinks, researchers can figure out the best way for patients to take this new tablet in the future, making sure it works as effectively as possible.
Key takeaways
- This is an early (Phase 1) study for a new medicine for inflammatory conditions.
- It aims to see how different drinks affect how the body absorbs the medicine.
- Only healthy adults aged 18 and over, both men and women, can take part.
- You won't be treated for an illness; the study is about understanding the drug.
- Taking part involves multiple clinic visits, taking the tablet, and blood tests.
- Your safety will be closely monitored throughout your participation.
Who may be eligible?
This study is looking for healthy adults to take part. To be suitable, you need to be aged 18 years or older – there is no upper age limit for volunteers. Both men and women are welcome to participate in this research.
Since this is an early-stage drug study, it is specifically for healthy individuals. This means you should not have any ongoing significant medical conditions. The researchers will carry out checks to make sure you are healthy and suitable 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 18 years old or older?
- Are you generally in good health?
- Do you not have any significant ongoing medical conditions?
- Are you willing to visit a clinic multiple times for the study?
- Are you comfortable with having blood samples taken regularly?
What does participation involve?
If you decide to take part, you would be asked to visit a research clinic multiple times. During these visits, you’ll be given the study tablet with different types of drinks. Researchers will then regularly take small blood samples to measure how much of the medicine is in your body. You might also have other checks like blood pressure or heart rate measurements. The study is designed to be a 'crossover' study, meaning you would try the tablet with different drinks at different times, with a break in between. The total time you'd be involved in the study, including all visits and follow-up, would be explained in full before you agree to take part.
Potential risks and benefits
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Common questions
What kind of medicine is JNJ 77242113?
It's a new tablet being developed to help with inflammatory conditions, but this study focuses on how the body absorbs it, not its effects on the illness itself.
Why do they need healthy people for this study?
Healthy volunteers help researchers understand how a new medicine works in the body without other health problems complicating the results. This is standard for early drug development.
Will I be given treatment for an illness?
No, this study is not designed to treat an illness. It's about understanding how a new medicine is absorbed in healthy people.
What does a 'crossover' study mean?
It means you'll try the tablet with different drinks at different times, allowing researchers to compare the effects of each liquid in the same person.
Will I have to stay overnight for the study?
The information doesn't say specifically, but these types of studies often involve longer clinic visits or overnight stays for blood sampling. This will be fully explained before you agree to join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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