Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Exploratory study to assess the pharmacokinetic interaction of doxepin with adrenaline after a concomitant co-administration using the Anapen® device and to compare the adrenaline comparative bioavailability with Anapen®500 commercial form in healthy normal weight male subjects

This research is an early-stage study to understand how two medicines, adrenaline and doxepin, interact in the body. Adrenaline is a crucial treatment for severe allergic reactions, known as anaphylaxis, and is often given using a special device like an Anapen. Doxepin is another type of medicine. This study aims to see if taking doxepin alongside adrenaline affects how adrenaline works when delivered by an Anapen. They also want to compare a new type of Anapen device against the Anapen 500, which is already used, to see if they deliver adrenaline in a similar way. This is done in healthy men to get a clear picture of how these medicines behave without other health conditions getting in the way.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bioprojet Pharma

Enrolment target

Start

25 Mar 2024

Anaphylaxis

What is this study about?

This study is an early-stage research project designed to understand how certain medicines interact within the body. Specifically, it's looking at adrenaline, which is a life-saving medication used to treat very serious allergic reactions called anaphylaxis. People who are at risk of anaphylaxis often carry an adrenaline auto-injector, such as an Anapen, which allows them to quickly give themselves the medicine in an emergency.

Researchers want to see what happens when adrenaline is given using an Anapen device at the same time as another medicine called doxepin. They want to find out if taking doxepin affects how adrenaline is absorbed and used by the body. This is important to ensure that adrenaline treatments work as expected, even if someone is also taking other medications. The study also aims to compare a new version of the Anapen device with the Anapen 500, which is already available on the market, to make sure they deliver adrenaline in a similar way.

Because this is an early-stage study, it's conducted in healthy volunteers. This helps researchers to focus on how the medicines work without other health problems complicating the results. The information gathered from studies like this helps doctors and pharmacists understand how to safely and effectively use these medicines together in the future, particularly for people who might need to take both.

Key takeaways

This is an early-stage study (Phase I) looking at adrenaline and doxepin.
It aims to understand how these medicines interact when taken together.
The study also compares a new Anapen device with an existing one.
Only healthy men aged 18 and over are being recruited.
Results will help improve medication safety for serious allergic reactions.

Who may be eligible?

This study is looking for healthy men to take part. To be eligible, you need to be at least 18 years old – there isn't an upper age limit mentioned.

Because this study is focused on how medicines work in the body without other health conditions affecting the results, it's likely that you would need to be generally fit and well. You would also need to be a healthy weight, as body weight can sometimes affect how medicines are absorbed and used by the body.

More specific details about your health, any other medicines you take, and your lifestyle would be discussed with the study team to confirm if this study is right for you.

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 male?
Are you 18 years old or older?
Are you generally healthy?
Are you a healthy weight?
Are you willing to attend multiple clinic visits and have blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive both doxepin and adrenaline (given via an Anapen device) at certain times. The research team would closely monitor how your body reacts to these medicines. This involves taking regular blood samples to measure the levels of the medicines in your system over a period of time. You would have several visits to the clinic for these assessments. The total duration of your participation would be explained fully by the study team, but typically, early-phase studies like this involve specific day visits and potentially some follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this research is helping us understand how these important medicines work together, which could improve safety for patients in the future. As for risks, you might experience side effects from the medicines, although these would be closely monitored. There are also risks associated with having regular blood tests, such as bruising or discomfort. 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
France

Common questions

What is anaphylaxis?

Anaphylaxis is a very severe allergic reaction that can be life-threatening and needs urgent medical attention.

What is an Anapen device?

An Anapen is a type of adrenaline auto-injector, a special pen that quickly delivers adrenaline to treat severe allergic reactions.

What does 'exploratory study' mean?

An 'exploratory study' is a very early stage of research, like a first look, to gather information and see if further study is needed.

Why are only men included in this study?

Sometimes, early studies focus on one sex to reduce differences between participants and get clearer results about how a medicine works, before expanding to other groups.

Will I get paid to participate?

Often, early-phase studies offer payment for your time and travel, but this would be confirmed by the study team.