Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019
This study is investigating a new drug called GRT6019. The main goal is to understand how a single dose of this drug moves through and is processed by the body in healthy men. Researchers will track exactly how much of the drug is absorbed, how it's changed into other substances (metabolites), and how it's eventually removed from the body. This is a very early-stage study, known as Phase 1, and will involve a small number of male volunteers aged 30 to 65. By understanding how the body handles GRT6019, scientists can gather important information for its potential future development.
At a glance
What is this study about?
This study is an important first step in understanding a new drug called GRT6019. Think of it like this: when you take any medication, your body starts to process it. This study aims to get a very detailed picture of this process for GRT6019. Researchers will trace a special version of the drug, which has a tiny, safe amount of a carbon-14 tracer, as it travels through the body.
The main purpose is to learn how much of the drug is absorbed, how it's broken down into other compounds (these are called metabolites), and how it's eventually passed out of the body. This is called 'mass balance recovery' and 'metabolite profiling.' Knowing all this helps scientists understand how the drug works, how long it stays in the system, and how it might affect the body.
This type of study is crucial because it provides foundational information about a new drug's journey within the body. This information is vital for deciding if and how to continue developing the drug for potential future use in patients. It's carried out in healthy volunteers to get a clear picture without other health conditions complicating the results.
Key takeaways
- This is an early-stage study (Phase 1) of a new drug, GRT6019.
- It aims to understand how a single dose of the drug travels through and is processed by the body.
- The study involves a small number of healthy men aged 30-65.
- Participation will last up to 11 weeks.
- Your contribution could help scientists develop future medicines.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be a healthy man between the ages of 30 and 65, inclusive. 'Healthy' means you generally don't have any significant medical conditions that would affect how your body handles medicines.
There are also some reasons why you couldn't join. For example, if you've ever had a severe allergic reaction to a drug, or if you have certain serious or long-standing health problems like heart, kidney, liver, or significant breathing issues, you wouldn't be able to take part. Also, if you have a history of serious stomach or bowel problems, such as Crohn's disease or ulcerative colitis, or if you've had major stomach surgery recently (other than an appendix removal or hernia repair more than a year ago), you wouldn't be suitable for this study.
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 a man aged between 30 and 65 years old?
- Are you generally healthy, without significant long-term illnesses?
- Have you ever had a severe allergic reaction to a medicine?
- Do you have serious heart, kidney, liver, or significant breathing problems?
- Do you have a history of serious stomach or bowel conditions, like Crohn's disease or ulcerative colitis?
- Have you had major stomach surgery (other than appendix or hernia repair over a year ago)?
What does participation involve?
If you decide to take part, you'll be one of up to ten healthy male volunteers. This is an 'open-label' study, meaning both you and the study team will know you're receiving the study drug. You will receive a single dose of the drug, GRT6019, which has a special marker on it to help researchers track it. Over the course of approximately 11 weeks, you'll have several visits to the clinic where the study team will carefully monitor your health and collect samples (like blood or urine) to track the drug's journey through your body. The total duration of your involvement in the study, from your first screening visit to your final follow-up, will be up to 11 weeks.
Potential risks and benefits
Locations (1)
- Quotient SciencesVerified postcodeNottingham, United Kingdom· Recruiting
Common questions
What is GRT6019?
GRT6019 is a new drug being investigated. This study is an early step to understand how it behaves in the body.
Why is the study only for men?
Many early-stage studies focus on one gender to simplify the initial data collection and reduce variability. This approach helps get clearer results in the first phase of testing.
What does 'Phase 1' mean?
'Phase 1' means this is one of the very first studies of a new drug in humans. It focuses on safety and how the body handles the drug, rather than how well it treats a specific illness.
Will I have to stay at the clinic?
The information provided suggests there will be clinic visits, but doesn't specify if an overnight stay is required. This would be explained in detail if you were to consider joining.
What is carbon-14 used for?
Carbon-14 is a safe, very small amount of a 'tracer' that helps researchers track the drug precisely as it moves through and is processed by your body.
How to find out more
Grünenthal Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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