A trial to learn about how multiple doses of itraconazole change how AZD5004 moves throughout the body over time in healthy adults and how multiple doses of AZD5004 change how ethinyl estradiol and levonorgestrel move throughout the body overtime in healthy female adults
This research study, called a Phase I trial, is designed for healthy adults. It aims to understand how a new investigational drug, AZD5004, behaves in the body when taken with itraconazole, a medicine often used for fungal infections. The study also investigates how AZD5004 might affect birth control pills, specifically ethinyl estradiol and levonorgestrel, in healthy women. By learning how these drugs interact and move through the body, scientists can better understand how to prescribe them safely and effectively in the future. This type of early study is important for developing new medicines.
At a glance
What is this study about?
This study is a type of early research often called a 'Phase I' trial. The main goal is to carefully examine how a new investigational drug, AZD5004, travels through and leaves the body over time. This is especially important when other medicines are also being taken, as drugs can often interact with each other in unexpected ways.
Specifically, the researchers want to see how taking itraconazole, a common medicine used to treat fungal infections, at the same time as AZD5004 affects how AZD5004 moves in the body. They also want to understand the reverse: how AZD5004 might change the way common birth control pill ingredients (ethinyl estradiol and levonorgestrel) behave in healthy women's bodies. Understanding these interactions is crucial for patient safety and for ensuring medicines work as intended.
By carefully studying these interactions in healthy volunteers, researchers can gather important information. This information helps them to later decide on the best ways to use AZD5004, and what precautions might be needed if patients are taking it with other common medications like anti-fungals or birth control pills. This foundational research is a vital step in the process of developing new treatments.
Key takeaways
- This is an early-stage study for healthy adults.
- It investigates how a new drug interacts with an anti-fungal medicine and birth control pills.
- The goal is to understand how drugs move through the body when taken together.
- Participation helps future patients by providing crucial drug interaction information.
- You will be closely monitored for safety throughout the study.
Who may be eligible?
This study is looking for healthy adult volunteers. 'Healthy' means you don't have any major ongoing health conditions that could affect the study results. You would need to be in generally good physical condition.
Participants must be aged 18 years or older. There is no upper age limit, so adults of any age from 18 upwards can be considered.
Both men and women are welcome to take part in this study. For women, the study will specifically look at how the drugs interact with common birth control pills.
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?
- Do you consider yourself generally healthy?
- Are you able to attend regular clinic visits?
- Are you comfortable with blood draws and health checks?
What does participation involve?
Taking part in this study would involve a series of visits to a clinic. During these visits, you would receive the study medications (AZD5004, itraconazole, and/or birth control pills, depending on the study group you are in). You might need to take these medications over several days.
Throughout the study, nurses and doctors will regularly take blood samples to measure the levels of the study drugs in your system. This helps them understand how the drugs are moving through your body. You will also have regular health checks, which might include things like measuring your blood pressure, heart rate, and temperature, and giving urine samples.
The total duration of your involvement, including all visits and follow-up, will be clearly explained to you before you agree to take part. It's important to be prepared for the time commitment involved.
Potential risks and benefits
Locations (1)
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Common questions
What is a Phase I study?
A Phase I study is the first step where a new drug is tested in humans, often healthy volunteers, to see how it moves through the body and if it's safe at different doses.
Will I receive treatment for a medical condition?
No, this study is for healthy volunteers and is not designed to treat any medical condition. Its purpose is purely for research.
What does 'drug interaction' mean?
Drug interaction means how one medicine can change the way another medicine works, or how it's handled by your body.
Do I have to take birth control pills for this study?
Only healthy female adults in specific parts of the study will be given birth control pills to understand how the new drug interacts with them.
How long will I need to be involved?
The exact duration will be explained by the study team, but Phase I studies often involve several visits over a few weeks or months.
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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