Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post-menopausal Female Subjects

This study is investigating a new medicine called camizestrant. It's specifically looking at how this medicine acts inside the body of post-menopausal women who have either moderate or severe liver problems. Researchers want to understand if having liver impairment changes how the body processes the medicine, including how much of it gets into the blood and how quickly it's removed. They will also be carefully monitoring the women to check for any side effects or discomfort, to make sure the medicine is safe and well-tolerated. This is a very early stage study, focusing on understanding the medicine's basic interactions with the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

Start

19 May 2023

moderate or severe hepatic impairment

What is this study about?

This research is focused on a new medicine called camizestrant. Before any new medicine can be widely used, scientists need to understand exactly how it behaves in the human body. This particular study is interested in how camizestrant works in post-menopausal women, especially those who have ongoing liver problems, whether moderate or severe.

Your liver plays a really important role in processing medicines — it often helps break them down and remove them from your body. If someone's liver isn't working as well as it should, it can change how a medicine acts. It might stay in the body longer, or in different amounts, which could affect how well it works or if it causes side effects. So, this study wants to see if liver problems change how camizestrant is handled by the body.

The main goals are to figure out if camizestrant is processed differently in women with liver problems and to check for its safety. This information is vital because it helps doctors know how to prescribe the medicine safely and effectively in the future, especially for patients who might have liver conditions.

Key takeaways

This study evaluates a new medicine (camizestrant) in post-menopausal women.
It focuses on how liver problems (moderate or severe) affect the medicine's behaviour in the body.
The study aims to understand the medicine's safety and how it is processed.
It is an early-stage study to gather essential information for future use.
Participation involves clinic visits, blood tests, and health monitoring.

Who may be eligible?

This study is for women who have gone through menopause, meaning they no longer have their monthly periods. You must be at least 18 years old to take part.

A key part of this study is that you must have either moderate or severe liver problems. The researchers want to understand how the new medicine works specifically in people with conditions affecting their liver.

More detailed checks will be done by the study team to make sure it's safe and appropriate for you to join. This might include reviewing your medical history and current health.

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 woman?
Have you gone through menopause (stopped periods completely)?
Are you 18 years old or older?
Have you been diagnosed with moderate or severe liver problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the study clinic several times. During these visits, you’d likely have blood tests taken to measure how the medicine is behaving in your body. You would also have regular health checks, like blood pressure measurements and perhaps other tests, to monitor your safety and well-being. You would be given the study medication, camizestrant, according to the study plan. The exact number of visits, tests, and total length of your participation would be explained in detail by the study team, but these types of studies often involve regular check-ins over a period of weeks to a few months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of joining this study is that you would be closely monitored by medical professionals, and you might contribute to important knowledge that helps future patients. However, as this is an early stage study, the main benefit is for scientific understanding rather than direct personal gain from the medicine. Potential risks could include side effects from the study medicine, discomfort from blood tests, or inconvenience from hospital visits. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Bulgaria
—
Unverified
Slovakia

Common questions

What does 'post-menopausal' mean?

It means you have completely stopped having your monthly periods, usually for at least 12 months.

What does 'hepatic impairment' mean?

It's a medical term for liver problems, where your liver might not be working as well as it should.

Will I receive treatment for my liver condition in this study?

No, this study is not designed to treat your liver condition. It's about how your liver condition affects a new medicine.

Is this a new medicine?

Yes, camizestrant is a new medicine being investigated in this early-stage study.

Will I know if I'm getting the active medicine?

In this type of study, everyone typically receives the active study drug according to the research plan, but this would be fully explained to you.