Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Single Ascending Dose, Single-Centre Study, to Assess Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Dose of Bedaquiline Long-Acting Injection Formulation in Healthy Participants

Doctors are running a study to test a new way of giving a medicine called bedaquiline, which is used to treat tuberculosis (TB). Instead of daily pills, this new version is a long-acting injection. The main goals are to make sure it's safe for people, to understand how the body uses and gets rid of it, and to see if this injection could be a better way to treat TB in the future. The study involves a single injection and will carefully check participants' health. This research is important for finding easier and more effective ways to help people with tuberculosis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Janssen Cilag International

Enrolment target

Start

24 Jun 2024

Tuberculosis

What is this study about?

This study is looking into a new way to give a very important medicine called bedaquiline, which is used to treat tuberculosis (TB). TB is a serious infection, mainly of the lungs, caused by bacteria. Currently, people often have to take medicines for a long time, sometimes every day, which can be difficult.

Researchers are developing a new version of bedaquiline that can be given as a single injection, designed to work in the body for a longer period. This study is the very first time this new injectable form of bedaquiline will be given to people. The main aim is to see if it is safe and well-tolerated, meaning whether people experience any bad side effects.

Another key part of the study is to understand how the body takes in, uses, and gets rid of this new medicine. This is called 'pharmacokinetics'. By understanding this, doctors can figure out the best way to use the medicine in the future. This research is a crucial first step in potentially making TB treatment much simpler and more effective for patients around the world.

Key takeaways

Tests a new, long-lasting injection for TB.
First time in healthy people to check safety and how it works.
Could make TB treatment easier in the future.
For adults aged 18 and over, both men and women.
Involves a single injection and careful health checks.

Who may be eligible?

This study is looking for healthy adult volunteers. You must be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome.

This is a 'first-in-human' study, meaning it's the first time this specific long-acting injection will be given to people. Because of this, they are looking for healthy individuals who don't have tuberculosis or any other major health problems.

Specific medical checks will be done by the study team to make sure it is safe for you to participate. They will be looking for people who are in good overall 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 18 years old or older?
Are you generally healthy with no major medical conditions?
Are you able to attend appointments at the study clinic?
Are you willing to have blood tests and other medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a clinic where the study is being held. You'll receive a single injection of the new bedaquiline medicine. The medical team will carefully monitor you during your visits.

Throughout the study, you'll have regular check-ups, which include blood tests, urine tests, and possibly other scans to see how your body is reacting to the medicine. The research team will explain everything in detail, including how often you'll need to visit, what each visit involves, and the total length of your participation. They will also keep track of any side effects you might experience.

Potential risks and benefits

Participating in a study like this helps advance medical science and could lead to better treatments for tuberculosis in the future. However, there's no direct personal benefit to you as a participant since you do not have TB. There are potential risks, as with any medicine, including side effects from the injection or the drug itself. These will be carefully explained to you. 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
Austria

Common questions

What is tuberculosis (TB)?

Tuberculosis is a bacterial infection that usually affects the lungs, but can also affect other parts of the body. It can be serious if not treated.

What does 'long-acting injection' mean?

It means the medicine is given as a single shot, but it stays and works in your body for a longer time, potentially replacing daily pills.

Will I get paid for taking part?

This information is not provided here, but it's a good question to ask the study team directly.

Do I have to take time off work or school?

The study involves clinic visits, so you may need to arrange your schedule accordingly. The study team can provide details on the time commitment.

What if I change my mind after joining?

You are free to leave the study at any point, for any reason, without needing to explain why. Your medical care will not be affected.