Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Phase 1, first-in-human trial to evaluate the safety, tolerability, and pharmacokinetics of ascending single oral doses of octreotide/ LipOra peptide in healthy volunteers

This is a very early study, called a Phase 1 'first-in-human' trial, to try out a new medicine for the first time in people. The medicine, called octreotide/LipOra peptide, is being given in single, increasing doses to healthy volunteers. Researchers want to make sure it's safe and doesn't cause serious side effects. They also want to understand how the body deals with the medicine – how it's absorbed, distributed, broken down, and removed. This is important information to gather before testing the medicine in people who are unwell. This particular medicine might eventually be used to help people with a condition called acromegaly, but this study isn't looking at treating that condition yet.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Universitaetsklinikum Heidelberg AöR

Enrolment target

Start

23 Aug 2024

Acromegalia

What is this study about?

This study is an important first step in developing a new medicine. It's called a 'Phase 1' study, which means it's one of the very first times a medicine is given to people, not to treat a specific illness yet, but to learn about its basic properties. Think of it like a new car being tested on a private track before it's driven on public roads. In this case, the 'car' is a new medicine called octreotide/LipOra, and the 'private track' is a group of healthy volunteers.

The main aim here is to see if the medicine is safe. The research team will give different volunteers single, increasing doses of the medicine and carefully watch for any side effects. They also want to understand how the medicine behaves in the body – how much is absorbed, how long it stays in the body, and how it's finally removed. This helps doctors figure out the best and safest way to give the medicine in future studies.

While this study is done in healthy people, the medicine is being developed for conditions like acromegaly. Acromegaly is a rare condition where the body produces too much growth hormone. Finding safe and effective treatments for conditions like this is why these early studies are so important, as they lay the groundwork for future research that could directly help patients.

Key takeaways

This is an early-stage study testing a new medicine in healthy people.
The main goals are to check safety, how the medicine is tolerated, and how it works in the body.
It's the first time this specific medicine is being given to humans.
The medicine is being developed for conditions like acromegaly, but this study isn't a treatment trial.
Participants must be healthy adults aged 18 or older.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or over. This study is open to both men and women.

Because this is a very early study looking at safety in healthy people, there might be other specific health requirements or conditions that would mean you couldn't join. For example, certain long-term health problems or regular medications might prevent someone from taking part, even if they generally feel well.

It's important to remember that not everyone who is interested will be able to join. The study team will need to check your health carefully to make sure it's safe for you to take part.

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 in good health?
Are you comfortable taking a new medicine?
Are you able to attend all study visits and appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check to make sure you are suitable. If you qualify, you would receive a single dose of the study medicine. This would involve taking a tablet. After taking the medicine, you would be carefully monitored by the study team, likely staying at the study clinic for a period of time. This monitoring would include regular health checks, blood tests, and perhaps other tests to see how the medicine is affecting your body and how it's being processed.

You would also have follow-up visits, which could involve further health checks and blood tests, to ensure you remain well and to collect all the necessary information about the medicine. The total time you would be involved in the study, from your initial checks to your final follow-up, would be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would be contributing to medical research, which could help develop new treatments for conditions like acromegaly in the future. You would also receive thorough medical check-ups during your participation. Potential risks could include side effects from the study medicine, which might be mild (like a headache or upset stomach) or, in rare cases, more serious. There's also the discomfort of blood tests or other procedures. The study team will explain all known or potential risks in detail before you decide to join. Remember, you have the right to withdraw from 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.

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Unverified
Germany

Common questions

What does 'first-in-human' mean?

It means this is the very first time this new medicine is being given to people, usually healthy volunteers, to check its basic safety before it's tested in patients with an illness.

What is 'acromegaly'?

Acromegaly is a condition where the body makes too much growth hormone, causing parts of the body to grow larger than usual.

Will I get the medicine for acromegaly during this study?

No, this study is about safety and how the medicine works in healthy people, not about treating acromegaly itself. Future studies would look at that.

How long will I be in the study?

The study team will tell you the exact duration, which includes screening visits, the day you take the medicine and are monitored, and any follow-up appointments.

Will I be paid for taking part?

Sometimes, volunteers receive payment for their time and expenses. The study team will give you all the details about this during the consent process.