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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study of exposure to substances prohibited by the World Anti-Doping Agency in healthy volunteers. Proof of concept.

This research study is for healthy volunteers and aims to understand how certain substances, which are banned in sports, affect the human body. This is a very early stage of research, often called 'Phase I'. It's about finding out how the body processes these substances and how they might affect different systems. The main goal is to gain a better understanding, not to test new treatments for diseases. By taking part, you would be helping scientists learn important information that could contribute to broader knowledge about these substances, which is valuable for areas like sports science and public health. Your safety and well-being would be carefully monitored throughout the study.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Municipal Institute Of Medical Investigation, Hospital Del Mar
Enrolment target
28
Start
13 Feb 2023

What is this study about?

Imagine you're curious about how certain ingredients in food or medicine affect your body. This study is a bit like that, but it focuses on specific substances that are considered 'banned' in professional sports. The researchers want to understand how these substances behave once they are inside a healthy person's body. This includes looking at how quickly the body absorbs them, how they are broken down, and how they are eventually removed.

This kind of research is known as a 'proof of concept' study and is typically one of the very first steps in understanding a new substance in humans. It's not about finding a cure for a disease or testing a new medication. Instead, it's about gathering fundamental information about these substances in healthy individuals. The knowledge gained from studies like this can be really important. For example, it might help scientists and doctors understand how these substances could affect people, which can then inform guidelines or future research, particularly in areas like sports medicine or toxicology.

By taking part, you would be contributing to scientific understanding. Your involvement would help researchers learn more about how the human body reacts to these particular substances in a controlled and safe environment. This fundamental understanding is crucial for a wide range of applications, even if it's not directly related to treating an illness.

Key takeaways

  • Study examines how healthy men react to specific banned substances.
  • This is an early-stage study to understand basic body processes.
  • No direct health benefit for participants is expected.
  • Participation involves clinic visits and regular monitoring.
  • Your health and safety are a top priority.
  • You can withdraw at any time without penalty.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There isn't an upper age limit mentioned, so if you're 18 or older, you might be able to take part.

This study is specifically looking for men. Women are not being recruited for this particular research. The researchers also need you to be generally healthy, meaning you don't have any major ongoing health conditions that could affect the study's results or your safety during the trial. They will do checks to make sure you fit this description.

It's important to remember that these are just the basic requirements. If you meet these, you would still need to go through a full screening process with the study team to confirm if you are suitable. They will ask more detailed questions about your health and medical history.

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 male?
  3. Do you consider yourself generally healthy?
  4. Are you able to attend appointments at a research clinic?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to visit a research clinic. During these visits, the study team would carefully monitor your health. You would receive the study substance, and they would regularly take samples, such as blood or urine tests, to see how your body is handling it. They might also check your vital signs like blood pressure and heart rate.

Each visit might involve spending several hours at the clinic. The total number of visits and the overall length of your participation in the study would be explained to you in detail before you agree to join. They will ensure you understand what to expect at every step, including any follow-up appointments after you've received the substance. You'll have all your questions answered about what exactly is involved and the time commitment required.

Potential risks and benefits

Taking part in any research study involves potential benefits and risks. A potential benefit of this study is contributing to valuable scientific knowledge, which can help others in the future. As this is an early-stage study, there isn't a direct personal health benefit expected for you. Potential risks could include discomfort from blood tests, temporary side effects from the study substance, or allergic reactions. The study team will explain all known or potential risks in detail, and your health will be closely monitored throughout. Remember, you can choose to withdraw from the study at any time, for any reason, without needing to explain why, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain

Common questions

What is the study trying to find out?

It's trying to learn how healthy bodies react to certain substances that are banned in sports, like how they are processed and leave the body.

Will I get 'better' from taking part?

No, this study isn't looking to treat an illness, so there isn't a direct health benefit for you. You'd be helping science.

What do you mean by 'healthy volunteers'?

It means people who generally don't have major ongoing health problems or illnesses that could affect the study.

Will I be compensated for my time?

The study team will provide details on whether you will be compensated for your time, travel, and inconvenience.

What happens if I change my mind?

You are free to leave the study at any point, for any reason, and it won't affect your regular medical care.

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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