Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Parallel Group Study to Evaluate the Safety, Pharmacokinetics, and Dose Response of Paltusotine Treatment in Subjects with Carcinoid Syndrome

This study is exploring a new tablet called Paltusotine for people who have Carcinoid Syndrome. Carcinoid Syndrome is a condition that can cause various symptoms, often related to certain tumours. The main goals of this research are to check how safe Paltusotine is, understand how the body uses it, and find out if different amounts (doses) of the medicine work better or worse. Researchers will be comparing Paltusotine to an established medication called Octreotide. This is a Phase II study, which means it’s an early step in testing the new drug to see if it has potential benefits and if it’s safe enough to study further. They'll be watching closely for any side effects and how the drug levels change in your body.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Crinetics Pharmaceuticals Inc.

Enrolment target

Start

06 Aug 2024

Carcinoid Syndrome

What is this study about?

This research is looking into a new tablet called Paltusotine. It's designed for people who have Carcinoid Syndrome, a condition linked to certain types of tumours that can release hormones, causing symptoms. Currently, a common treatment for Carcinoid Syndrome is Octreotide. This study wants to see if Paltusotine could be another option for managing the condition.

The main aim of the study is to find out if Paltusotine is safe for people to take and to understand how it behaves in the body. Researchers will also test different doses of the new tablet to see which amount might work best and have the fewest side effects. They will compare these findings with people who receive Octreotide, a medication already used for this condition.

By taking part, you would help doctors learn more about Carcinoid Syndrome and potentially contribute to finding new and better ways to treat it in the future. It’s an important step in developing new medicines.

Key takeaways

Tests a new tablet, Paltusotine, for Carcinoid Syndrome.
Compares it to an existing treatment, Octreotide.
Focuses on safety and how the drug works in the body.
Includes regular health checks and heart monitoring.
Open to adults aged 18 and over, both men and women.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part in this research.

The research team will have specific medical criteria to decide if this study is right for you. This often includes checks on your current health, any other medications you are taking, and a review of your medical history related to Carcinoid Syndrome.

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?
Do you have a diagnosis of Carcinoid Syndrome?
Are you able to take tablets?
Are you willing to attend multiple clinic visits?
Are you comfortable with regular blood tests and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the new tablet, Paltusotine, or the existing treatment, Octreotide. The doctors would regularly check your health throughout the study. This would involve various assessments like blood tests to check your lab results, physical examinations, measuring your vital signs (like blood pressure and heart rate), and heart tracings (ECGs).

For some participants, particularly those taking a higher dose of the new tablet, there might be additional heart monitoring over a full day. The study team will explain how often you would need to attend appointments and how long you would be involved in the study in total. They will monitor drug levels in your body at different times to understand how the medication is working.

Potential risks and benefits

Potential benefits of joining the study could include receiving careful medical attention and possibly receiving a new treatment that might help manage your Carcinoid Syndrome. However, there's no guarantee that the new drug will be better than existing treatments, or even that it will help at all. Potential risks could include experiencing new side effects from the medication. Even though new drugs are carefully tested before studies like this, all medications can have unexpected effects. The research team will explain all known potential side effects. Remember, taking part in any study is completely your choice, and you have the right to withdraw at any time without giving a reason, and this will not affect your future 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
Poland

Common questions

What is Carcinoid Syndrome?

Carcinoid Syndrome is a group of symptoms that can happen when certain types of tumours, often in the gut, release hormones into your bloodstream. Symptoms can vary but often include flushing, diarrhoea, and wheezing.

What is the purpose of this study?

The study aims to see how safe a new tablet called Paltusotine is for people with Carcinoid Syndrome, how it works in the body, and if different doses have different effects compared to an existing treatment, Octreotide.

Will I definitely get the new tablet?

This is a 'randomized' study, meaning you will be randomly assigned to receive either the new tablet (Paltusotine) or the existing treatment (Octreotide). You won't get to choose which one you receive.

What does a 'Phase II' study mean?

Phase II studies are an early stage of testing new medicines. They focus on whether the drug is safe and if it shows some promise in treating the condition, while also trying to find the best dose.

How long will I be in the study if I join?

The study team will give you a clear schedule of visits and the total expected duration of your participation during the consent process, as it can vary.