Relative bioavailability and safety study of pasireotide after a single-dose subcutaneous administration in the arm or in the thigh compared to in the abdomen using a ServoPen in healthy subjects.
This research study is testing a new medicine called pasireotide. It's designed to help people with a condition called post-bariatric hypoglycaemia. In this study, we want to see how well the medicine is absorbed into the body when given as a single injection under the skin. We are comparing different injection sites: the arm, the thigh, and the tummy (abdomen). The injections will be given using a special device called a ServoPen. This study is for healthy volunteers, and a key goal is to check the medicine's safety. This is an early stage of testing, focusing on understanding how the medicine works in the body.
At a glance
What is this study about?
This study is about a new medicine called pasireotide, which is being developed to help people with a condition called post-bariatric hypoglycaemia. This condition can sometimes happen after weight-loss surgery (bariatric surgery) and causes blood sugar levels to drop too low, which can be uncomfortable or even dangerous. The medicine is given by an injection under the skin.
The main purpose of this particular study is to understand how the body takes in and uses this medicine when it's injected. We are specifically comparing three different injection sites: the arm, the thigh, and the tummy. This helps us find the best and most consistent way for the medicine to get into your system. We're also using a special device, called a ServoPen, for giving the injection, and checking how well that works.
This is a 'Phase I' study, which means it's one of the first times this medicine is being tested in people. Because it's an early study, we're focusing a lot on safety – making sure the medicine doesn't cause any unexpected problems. The volunteers taking part will be healthy adults, which helps us understand how the medicine works without other health conditions getting in the way.
Key takeaways
- Tests a new medicine for low blood sugar after weight-loss surgery.
- Compares injections in the arm, thigh, and tummy.
- Uses a special injection pen called a ServoPen.
- Only for healthy adults aged 18 and over.
- Main focus is on understanding how the medicine works and its safety.
- Participants receive a single dose of the active medicine.
Who may be eligible?
This study is open to healthy adults, both men and women. You must be at least 18 years old to take part, and there is no upper age limit mentioned, meaning older adults can also be considered.
To be eligible, you'll need to be in good general health. This usually means you don't have any significant ongoing medical conditions that could interfere with how the medicine works or make your participation unsafe.
The research team will carry out a full health check to make sure the study is right for you and that you meet all the specific requirements. They will explain everything clearly during this screening process.
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 18 years old or older?
- Are you generally healthy with no major ongoing medical conditions?
- Are you able to attend all study appointments as required?
- Are you comfortable receiving an injection under the skin?
- Are you comfortable with regular blood tests?
What does participation involve?
If you decide to take part, you will receive a single injection of the study medicine, pasireotide. This injection will be given under the skin in either your arm, thigh, or tummy, using a special pen device. Before and after the injection, the study team will take blood samples to measure how the medicine is absorbed and leaves your body. You will also have regular health checks, including measurements like blood pressure and heart rate, and answer questions about how you are feeling to monitor for any side effects. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but typically, single-dose studies involve a longer initial stay at the clinic followed by a few follow-up appointments.
Potential risks and benefits
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Common questions
What is post-bariatric hypoglycaemia?
It's a condition where blood sugar levels drop too low after having weight-loss surgery.
Why are you injecting in different body parts?
We want to find out if the medicine is absorbed differently depending on where it's injected.
Will I get the actual medicine or a dummy injection?
In this specific study, all participants will receive the active study medicine, pasireotide.
How long will I need to be involved in the study?
The full duration will be explained by the study team, but single-dose studies usually involve a longer visit for the dose and then some follow-up checks.
Who is paying for this study?
The study is sponsored by the company developing the medicine. The research team can provide more details.
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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