Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A PHASE 1 STUDY TO ASSESS THE EXCRETION BALANCE, PHARMACOKINETICS, AND METABOLISM OF 14CDC806 IN HEALTHY VOLUNTEERS

This research is a Phase 1 study, which means it's one of the first times this new drug, DC-806, is being given to people. The main goal is to understand how the body handles the drug once it’s taken. Researchers will track how it's absorbed, how it breaks down (metabolism), and how it eventually leaves the body, mainly through urine and faeces. They will also look at safety, checking for any side effects and monitoring basic health signs like heart rate and blood tests. This information is crucial for developing safe and effective new medicines in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Dice Therapeutics Inc.

Enrolment target

Start

02 Aug 2023

Healthy

What is this study about?

This study is a very early stage of investigating a new drug called DC-806. It's what we call a 'Phase 1' study, and its main purpose is to understand how the drug behaves inside the human body. Think of it like learning the journey of a new substance through your system.

Researchers want to find out how much of the drug gets into your bloodstream, how long it stays there, and how your body processes it. They’ll also be very interested in how your body gets rid of the drug, primarily by checking samples of urine and faeces. This helps them understand the full 'life cycle' of the drug in a healthy person.

While the main focus is on how the drug moves through the body, the study will also carefully monitor volunteers for any side effects or changes in their health. This includes checking vital signs like heart rate, taking blood tests, and performing heart scans (ECGs). All this information is essential before a new drug can be tested in patients who might benefit from it.

Key takeaways

This study is testing a new drug called DC-806 in healthy men.
It aims to understand how the body handles the drug (how it's used and removed).
Participation involves taking the drug and having regular medical checks and samples collected.
This is a Phase 1 study, one of the first steps in testing a new medicine.
You must be a healthy male, 18 years or older, to be considered.
Your participation helps advance medical research for future treatments.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but other health checks would likely apply.

When you volunteer for a study like this, the research team will ask you questions about your health and lifestyle, and you'll have medical checks to make sure you're suitable. This is important to ensure your safety and that the study results are clear.

It's important to remember that this study is for healthy people, not those with existing medical conditions. If you're a healthy man over 18 and interested, you might be able 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 a man?
Are you 18 years old or older?
Are you generally healthy, without significant long-term medical conditions?
Are you comfortable with blood tests, urine collection, and other health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive doses of the study drug, DC-806. Some of these would be a special version that helps researchers track it in the body. You would have regular medical checks, including blood and urine samples taken, to see how your body is handling the drug and how it's leaving your system.

Researchers will also monitor your vital signs, such as heart rate and blood pressure, and perform electrocardiograms (ECGs) to check your heart. They will also take blood tests to check your general health. You may need to collect all your urine and faeces during certain periods to help understand the drug's excretion.

Punctual attendance at all scheduled appointments is crucial. The total duration of your involvement in the study, including all visits and follow-up, would be fully explained to you before you agree to participate.

Potential risks and benefits

The main benefit of taking part in a study like this is contributing to medical science and helping develop new medicines that could help many people in the future. As this is an early-stage study, the potential direct benefit to you as an individual is generally limited, but you will receive medical check-ups throughout. Potential risks include side effects from the study drug, which could range from mild discomfort to more serious reactions, although these studies are designed to be as safe as possible with extensive monitoring. You will be fully informed of all known and potential risks before you consent to participate. 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.

—
Unverified
Netherlands

Common questions

What is the main goal of this study?

The main goal is to understand how a new drug, DC-806, is absorbed, processed, and removed from the body in healthy men.

Who can take part in this study?

Only healthy men aged 18 or older are eligible to participate.

Will I receive a new medicine as part of the study?

Yes, you will receive doses of the new drug called DC-806.

What kind of tests will I have?

You'll have blood and urine tests, vital signs checked, and heart scans (ECGs) to monitor your health and how your body handles the drug.

Is this drug meant to treat a disease?

No, this is a very early study focusing on understanding the drug's journey in healthy people, not treating a specific disease yet.