Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

Bioequivalence of Cladribine 10 mg from two different products

This research is a 'bioequivalence study,' which means scientists are comparing two different versions of the same drug, called cladribine. They want to check if both versions deliver the same amount of the drug to the body and work in the same way. This particular study involves healthy men, not people with an illness. The cladribine drug itself is intended to treat adults with a very active form of multiple sclerosis (MS) in the future. By doing this study, researchers can ensure that if one of these cladribine products is used for MS, it will be just as effective as another version, aiming for consistent and reliable treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, Pharos Pharmaceutical Oriented Services Ltd.

Enrolment target

Start

06 Feb 2024

No therapeutic indication in the current trial with healthy volunteers. The intended indication is for treatment of adult patients with highly active relapsing multiple sclerosis (MS).

What is this study about?

Imagine you have a regular headache tablet, and then a different company makes their own version of the same tablet. This study is a bit like that – it's comparing two versions of a specific medicine called cladribine. The main goal is to check if these two versions release the same amount of the drug into your body at the same speed. If they do, they are considered "bioequivalent," meaning they should have the same effect.

It's important to know that this study is not testing cladribine as a treatment for any condition right now. Instead, it's a foundational step. The drug cladribine is being developed as a potential treatment for adults who have a highly active form of multiple sclerosis (MS). MS is a condition that affects the brain and spinal cord, and a highly active form means the disease is causing frequent problems.

By ensuring these different cladribine products are bioequivalent, researchers can be confident that if one is chosen for patient use, it will work safely and predictably, just like another version. This helps in developing reliable and effective medicines for people who might need them in the future.

Key takeaways

This study compares two versions of cladribine, a drug for MS.
It needs healthy male volunteers, aged 18 and over.
The goal is to ensure both versions of the drug work the same way in the body.
This is a first step in testing a new medicine for future MS treatment.
Participation includes taking the drug, blood tests, and clinic stays.

Who may be eligible?

To join this study, we are looking for volunteers who are adult men, specifically aged 18 years or older. There is no upper age limit for participation.

It's important to note that this study is specifically for healthy volunteers. This means you should not have any ongoing health conditions or be taking regular medications for an illness. The purpose is to see how the drug works in a healthy body, without other health issues potentially affecting the results.

This study is not for women, nor is it for anyone under the age of 18. Also, if you have multiple sclerosis or any other medical condition, this specific trial would not be suitable 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 male?
Are you 18 years old or older?
Are you generally healthy?
Do you not have multiple sclerosis or any other ongoing medical condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the cladribine medicine. There will be multiple visits to the study clinic, including overnight stays, so doctors can carefully monitor how the drug behaves in your body. This will involve regular blood tests to check drug levels and other health assessments like checking your heart rate and blood pressure.

You will receive both versions of the cladribine drug at different times during the study to allow for comparison. There will be periods when you're not taking the drug (called 'washout periods') between doses. The total time you'd be involved, including all visits and follow-ups, would be explained in detail before you agree to participate.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical science and helping develop new treatment options for people with multiple sclerosis. It also helps ensure future medications are safe and work as expected. As this is a study for healthy volunteers, you would not personally receive direct health improvements to an existing condition. Like all medicines, cladribine can have side effects, even in healthy individuals. You might experience common side effects such as headaches, feeling sick, or tiredness. More serious side effects are possible but rare, and you would be closely monitored for any reactions. 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
Bulgaria

Common questions

What is cladribine?

Cladribine is a medicine being developed to treat adults with a type of multiple sclerosis (MS).

Why are healthy people needed for this study?

Healthy volunteers help researchers understand how the drug works in the body without other health conditions affecting the results.

Will I get treated for MS in this study?

No, this study is not for treating MS. It's comparing two versions of a drug for future MS treatment.

What is a 'bioequivalence study'?

It's a study that checks if two different versions of the same drug deliver the same amount of medicine to your body.

Will I have to stay overnight for this study?

Yes, taking part will likely involve some overnight stays at the study clinic for close monitoring.