Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate the effect of ASTX660 (tolinapant) on the pharmacokinetics of substrates of OCT1, OCT2, and MATE1 in healthy volunteers

This research study is for healthy volunteers and is looking at a new medicine called ASTX660, also known as tolinapant. It's a very early-stage study, meaning it's one of the first times this medicine is being given to people. The main goal is to understand how your body handles this medicine. We are particularly interested in knowing if it changes how your body uses or gets rid of other common medicines you might take. This information is important for doctors to understand how to safely prescribe this new medicine in the future, if it proves helpful for treating illnesses. Participation is open to adults over 18 years old, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Taiho Oncology Inc.

Enrolment target

Start

23 Oct 2023

Not applicable. Healthy Volunteers

What is this study about?

This study is about a new medicine called ASTX660, also known as tolinapant. When a new medicine is developed, scientists need to understand exactly how it works in the body. This includes how it enters the body, how it travels to different places, and how the body eventually gets rid of it. This process is called 'pharmacokinetics.'

One very important part of understanding new medicines is finding out if they affect how other medicines are handled by your body. Our bodies have special 'transporters' (imagine them like tiny delivery trucks) that help move medicines in and out of our cells and organs. If a new medicine changes how these transporters work, it could affect how well other medicines work, or even make them cause more side effects.

So, in this study, we're giving ASTX660 to healthy volunteers to see if it changes the activity of some of these important transporters. Knowing this will help doctors understand how to safely use ASTX660 alongside other treatments in the future, should it prove to be a useful medicine for patients. It's a very early-stage study, which means we are still gathering basic information about how this medicine behaves in people.

Key takeaways

This is an early-stage study of a new medicine called ASTX660 (tolinapant).
It's for healthy adult volunteers, not people with a specific illness.
The main goal is to understand how the medicine moves and works in the body.
Researchers want to see if it affects how other medicines are handled by your body.
Your participation helps gather important safety information for future treatments.
You must be at least 18 years old to take part.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you don't have any serious ongoing medical conditions that would make taking part unsafe.

You must be at least 18 years old. There is no upper age limit, meaning older adults can also take part as long as they are healthy.

Anyone can participate, whether you are male or female. The research team will do medical checks to make sure the study is safe for you.

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 serious existing medical conditions?
Are you willing to attend regular clinic visits?
Are you comfortable with providing blood and urine samples?
Are you able to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given the study medicine, ASTX660, in a controlled setting. You will have several visits to the study clinic where doctors and nurses will monitor your health closely. This will involve giving blood and urine samples so that researchers can measure how the medicine moves through your body.

You might also be given small amounts of other 'test' medicines (that are already approved and known) to see how ASTX660 affects their levels in your body. The exact number of visits, tests, and the total duration will be explained in detail by the study team, as this information wasn't provided in the brief summary. You will be monitored throughout and after the study period.

Potential risks and benefits

As with any medicine, there's always a chance of side effects, even in healthy volunteers. The medical team will explain any known or potential risks in detail before you decide to join. You will be closely monitored for any reactions during the study. The main benefit for you individually is contributing to medical science and helping doctors understand new medicines better. For others, this study helps gather important safety information that could lead to new treatments in the future. 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 is ASTX660 (tolinapant) being developed for?

This study is in healthy volunteers, so we are not testing it for a specific illness yet. We are just learning how it works in the body.

Will I get paid for taking part?

The information provided does not say if you will be paid. This is a good question to ask the study team if you are interested.

How long will the study last if I join?

The summary doesn't specify the exact duration. The study team will tell you how long your participation would be if you inquire.

Will I need to stay in a hospital?

The summary doesn't say. Some early-stage studies require overnight stays, while others are outpatient visits. You should ask the study team this question.

Can I take my usual medicines during the study?

This study looks at how ASTX660 affects other medicines. So, you might need to stop some medicines or specific instructions will be given. Discuss all your current medicines with the study team.