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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

The Attractive 2 trial – An open-label, randomised, 2-period cross-over trial to assess the pharmacokinetics of ATR-258 oral capsule vs. oral solution formulations in healthy volunteers

The 'Attractive 2' study is a clinical trial looking at a new medicine called ATR-258, which is being developed to help people with type 2 diabetes. In this study, we are inviting healthy adult volunteers to participate. The main goal is to compare how two different versions of the same medicine – a capsule and a liquid – are absorbed and used by the body. By understanding this, researchers can work out the best way to give the medicine in the future. This is an early-stage study, meaning it's one of the first times this medicine is being tested in people.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Atrogi AB
Enrolment target
12
Start
22 Feb 2024

What is this study about?

Imagine you have a new car, and you want to know if it runs better on petrol from one pump or another. This study is a bit like that, but for a new medicine called ATR-258. This medicine is designed for people living with type 2 diabetes, a common condition where the body has trouble controlling blood sugar levels.

In this study, called 'The Attractive 2 trial', we're looking at two different ways to take ATR-258: as a capsule (like a pill) or as a liquid solution. We want to understand how each form travels through the body, how quickly it's absorbed, and how long it stays in the system. This information is really important because it helps scientists decide which form of the medicine will work best and be safest for patients in the long run.

Because this is an early study, we're asking healthy adults to volunteer. This helps us see how the medicine works without other health conditions affecting the results. By taking part, you'll be helping researchers learn more about ATR-258 and potentially contribute to a new treatment option for type 2 diabetes in the future.

Key takeaways

  • This study is testing a new medicine (ATR-258) for type 2 diabetes.
  • It wants to see how a capsule works compared to a liquid form.
  • Healthy volunteers aged 18 and over are needed.
  • It's an early-stage study to learn how the medicine behaves in the body.
  • Your participation will help advance treatments for type 2 diabetes.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should be generally well and not have any serious ongoing health problems.

You must be at least 18 years old to be considered for this study. There is no upper age limit, meaning older adults can also take part if they meet the other health requirements.

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

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.

  1. Are you 18 years old or older?
  2. Are you generally healthy with no serious ongoing medical conditions?
  3. Are you able to attend several study visits?
  4. Are you comfortable with blood samples being taken?
  5. Are you interested in helping medical research?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive both the capsule and liquid forms of the medicine, but at different times. This means you would visit the study clinic or hospital on a few separate occasions. During these visits, the study team would monitor your health carefully, take blood samples to see how the medicine is moving through your body, and ask you questions about how you're feeling. The study is designed to involve two separate periods where you receive the medicine, with a break in between. The total duration of your involvement, including all visits and follow-ups, would be explained in full detail by the study team.

Potential risks and benefits

While there aren't direct health benefits from taking part, your contribution will help scientists learn more about this new medicine for type 2 diabetes. As with any medicine, there's always a chance of side effects, which the study team will explain fully. You will be closely monitored, and your safety is the top priority. Remember, you can choose to leave 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.
  • Unverified
    Sweden

Common questions

What is type 2 diabetes?

Type 2 diabetes is a common condition where your body doesn't use insulin properly, leading to high blood sugar levels.

Why are you testing in healthy volunteers?

Testing in healthy volunteers helps us understand how the new medicine works in the body without other health conditions interfering with the results.

What does 'pharmacokinetics' mean?

Pharmacokinetics simply means how the medicine travels through your body – how it's absorbed, distributed, processed, and leaves your system.

Will I get the new medicine permanently?

No, this is a short-term study to gather information about the medicine. You will not receive the medicine permanently after the study ends.

Is this a new medicine for diabetes?

Yes, ATR-258 is a new medicine being developed to treat type 2 diabetes.

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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