A study in healthy volunteers to assess how the test medicine (IB1001) affects how the body takes up Digoxin and Rosuvastatin (Part 1) and how food affects blood levels of IB1001 (Part 2)
This early-stage study is testing a new medicine called IB1001, which is being developed for rare brain and nerve conditions like Niemann-Pick disease and ataxia telangiectasia. We're looking for healthy volunteers, aged 18 to 55, to help us understand two main things: First, how IB1001 affects the levels of common medicines like Digoxin and Rosuvastatin in the body. Second, whether eating food changes how IB1001 is absorbed into your bloodstream. The study will also help us learn more about any side effects and how safe the medicine is. This is a crucial step in developing new treatments for these serious conditions.
At a glance
What is this study about?
Researchers are developing a new medicine, IB1001, to potentially help people with rare brain and nerve conditions such as Niemann-Pick disease, GM2 gangliosidosis, and ataxia telangiectasia. These conditions affect how the brain and nervous system work. Before this new medicine can be tested in people who have these conditions, we need to understand how it behaves in the body and if it's safe.
This study is designed to answer some important early questions about IB1001 in healthy volunteers. Firstly, we want to see if taking IB1001 at the same time as other common medicines, Digoxin (often used for heart conditions) and Rosuvastatin (for high cholesterol), changes how much of those medicines get into your blood. This is important to know if people might need to adjust their regular medications. Secondly, we want to find out if eating food affects how much IB1001 gets absorbed into the bloodstream, which helps us understand the best way for people to take this medicine.
By taking part, you'll be helping us gather vital information on how IB1001 works and whether it causes any side effects. This information is a necessary step to see if IB1001 could be a safe and effective treatment for the neurological conditions it aims to help. Your contribution will bring us closer to potentially finding new treatments for these debilitating diseases.
Key takeaways
- New medicine (IB1001) for rare brain/nerve disorders being tested.
- Study looks at how medicine interacts with common drugs and food.
- Healthy volunteers aged 18-55 are needed.
- Involves clinic stays, blood/urine samples, and medical checks.
- No direct health benefits for participants, but valuable for research.
- Payment provided for participation.
Who may be eligible?
This study is looking for healthy men and women who are not pregnant or breastfeeding. You need to be between 18 and 55 years old. Before you can join, a doctor will check your general health through a medical exam, blood tests, urine tests, and an ECG (a heart tracing).
There are also some specific health requirements. You should not have any serious allergies, unless it's minor hay fever that isn't currently active. You also shouldn't have any major ongoing health problems affecting your heart, kidneys, liver, skin, lungs, stomach/intestines, brain, or mental health. Your body weight and height (BMI) should be within a healthy range, and you should weigh at least 50 kg.
Some things would prevent you from taking part, such as having a history of serious reactions to medicines, or certain infections like hepatitis B, C, or HIV. You also need to have veins that are suitable for taking regular blood samples.
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 between 18 and 55 years old?
- Are you generally healthy, with no major ongoing medical conditions?
- Are you either a man, or a woman who is not pregnant or breastfeeding?
- Do you have a body weight of at least 50 kg and your height and weight are suitable (BMI of 18.0 to 32.0 kg/m2)?
- Are you willing to use contraception if you are a woman who could become pregnant?
- Are you able to stay in a clinic for a few nights and attend follow-up appointments?
What does participation involve?
If you take part, the study involves two separate parts, and you might participate in either one or both. Both parts will involve staying at a clinic and having some outpatient visits.
In Part 1, you'll stay in the clinic for 12 nights, and have one follow-up visit after you leave. The entire study for you would take about 7 weeks. During your stay, you'll take a single dose of Digoxin and Rosuvastatin. After a short break, you'll take Digoxin and Rosuvastatin again, but this time you'll also take the new medicine, IB1001, three times a day for 5 days.
In Part 2, you'll stay in the clinic for 3 nights, with one follow-up visit. This part of the study would take about 6 weeks. You'll take two single doses of IB1001. One dose will be taken after you've eaten food, and the other will be taken when you haven't eaten (fasting). The order in which you take these is decided by chance. There will be a 24-hour break between the two doses.
Throughout both parts, we'll collect blood and urine samples to check your general health and measure the levels of the study medicines in your body. You'll also need to follow certain rules, like avoiding some foods or drinks at specific times, and women who could become pregnant will need to use effective contraception.
Potential risks and benefits
Locations (1)
- Quotient SciencesApproximateNottingham, England
Common questions
What is IB1001?
IB1001 is a new medicine being developed to treat rare brain and nerve disorders, like Niemann-Pick disease.
Why is this study needed?
This study helps us understand how IB1001 works in the body, if it interacts with other common medicines, and if food affects it, which are important steps before it can be tested in patients.
Will I get any medicine to treat an illness?
No, this study is for healthy volunteers and is designed to understand the medicine's effects, not to treat any existing condition you might have.
How long will I be involved in the study?
Depending on which part you join, you could be involved for 3 nights in the clinic and up to 6 weeks total, or 12 nights in the clinic and up to 7 weeks total.
Will I be paid for taking part?
Yes, you will receive payment for your time, inconvenience, and expenses related to participating in the study.
How to find out more
Taylor Fields
Always speak to your GP or specialist before deciding to take part in a study.
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