Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An open-label, healthy subject, two-part study to assess the effect of verapamil on systemic exposure of EP395 (Part A), and to assess the effect of EP395 on systemic exposure of midazolam and digoxin (Part B)

This study is designed for healthy volunteers to understand how different medications interact with each other. Researchers want to see if a medication called verapamil changes how much EP395 stays in the body. In a separate part of the study, they also want to see if EP395 affects how other common medications, midazolam (often used for relaxation before procedures) and digoxin (a heart medicine), stay in the body. This is a very early-stage study, meaning it’s one of the first times these specific drug interactions are being carefully looked at in people. The information gathered will help doctors understand how to prescribe these medicines safely in the future, particularly for people with conditions like COPD.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Epiendo Pharmaceuticals ehf., Epiendo Pharmaceuticals ehf.

Enrolment target

Start

26 Sep 2023

Chronic obstructive pulmonary disease (COPD)

What is this study about?

This research study is about understanding how certain medicines interact with each other within your body. Think of it like this: when you take two different pills, sometimes one can change how the other one works, or how long it stays in your system.

Specifically, this study has two main parts. In the first part, researchers want to see if a heart medication called verapamil affects a new medicine known as EP395. They'll be checking if verapamil causes more or less of EP395 to be in your blood. In the second part, they’ll look at the other way around: does EP395 change how much of other common medicines, midazolam and digoxin, stay in your body?

Understanding these interactions is really important for doctors and patients. It helps make sure that medicines are prescribed safely and work as expected, especially when someone needs to take several different drugs at the same time. While the study mentions COPD, this particular research is being done in healthy volunteers first to get a clear picture of how these drugs behave without other health conditions complicating the results.

Key takeaways

This study investigates how different medicines affect each other in healthy people.
It helps understand drug interactions for safer prescribing in the future.
Participation involves taking study drugs, regular clinic visits, and blood tests.
You must be 18 or older and in good general health.
All potential risks will be explained, and you can leave at any time.

Who may be eligible?

This study is looking for healthy adults. You need to be 18 years old or older to take part; there's no upper age limit mentioned.

Both men and women are welcome to volunteer for this study.

Crucially, you would be considered 'healthy,' meaning you don't have any major ongoing health conditions that would affect the study results, even though the broader research areas might relate to conditions like COPD.

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.

Am I 18 years old or older?
Do I consider myself generally healthy?
Am I able to commit to several clinic visits and assessments?
Am I comfortable with having blood tests and possibly staying overnight?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medications (EP395, verapamil, midazolam, and/or digoxin) as directed by the research team. This study involves several visits to the study clinic, which would include physical exams, blood tests, and other assessments to monitor your health and how the drugs are affecting your body. You might need to stay overnight for some visits. There will also be follow-up appointments after you've finished taking the study drugs. The total duration of your involvement in the study would be explained in detail before you agree to participate.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge that could help future patients use these medications more safely and effectively. You might also receive free health checks during your participation. Potential risks could include side effects from the medications, discomfort from blood tests, or inconvenience from hospital visits. All potential risks will be thoroughly explained, and 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
Sweden

Common questions

What does 'healthy subject' mean in this study?

It means the study is looking for people who generally don't have any major health problems that could affect how the medicines work or interact.

Why are they studying these medications together?

Researchers want to understand if taking these medicines at the same time changes how they act in your body. This helps doctors prescribe them safely.

Will I get paid for taking part?

The study information doesn't say, but it's a good question to ask the research team if you’re interested.

What is Midazolam and Digoxin?

Midazolam is medicine often used to help people relax before medical procedures. Digoxin is a medicine used to treat certain heart conditions.

Is EP395 a new medicine?

Yes, EP395 is a new medication, and this study is part of the early stages of understanding how it works and interacts with other drugs.