Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-7602 in Healthy Participants

This clinical study is investigating a new potential medicine, called MK-7602, which is being developed to treat malaria. It's an early-stage trial, meaning it's one of the first times this medicine is being given to people. The main goals are to carefully check its safety and how well healthy volunteers tolerate it. Researchers will also be looking at how the body processes the medicine, including how much of it gets into the blood, how long it stays there, and how it's eventually cleared from the body. This information is crucial for understanding if MK-7602 is safe enough to move forward into larger studies with people who have malaria, with the hope of finding new ways to combat this disease.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

Start

02 May 2023

Malaria

What is this study about?

This study is all about a new medicine called MK-7602, which doctors hope could one day help people with malaria. Malaria is a serious disease spread by mosquitoes, and new treatments are always needed to fight it effectively.

Because this is a brand-new medicine, the first step is to test it in a small group of healthy people. This is called a Phase I study. The main aim is to make sure the medicine is safe and that people can take it without too many problems. Researchers will give different doses to see how the body reacts and to find out the best way to give the medicine in the future.

They're not just looking at safety, though. They also want to understand what happens to the medicine once it's in your body. This includes how much of it gets into your blood, how long it stays there, and how quickly your body gets rid of it. This information is really important because it helps scientists work out the right dose for when they eventually test it in people who actually have malaria. Think of it as laying the groundwork for a potential future treatment.

Key takeaways

This study is testing a new malaria medicine called MK-7602.
It's an early-stage study primarily checking safety and how the body handles the medicine.
Healthy adult volunteers are needed for this research.
Participation involves taking the medicine and having regular health checks.
The goal is to gather information for potential future malaria treatments.

Who may be eligible?

To be able to take part in this study, volunteers must be healthy adults. This means you generally feel well and don't have any major ongoing health problems.

Participants need to be aged 18 years or older. There isn't an upper age limit mentioned, but you would still need to meet the general health requirements.

Both men and women are welcome to participate in this study. The research team will ask you some questions and do some checks to make sure this study is right for you and that taking part would be safe.

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?
Do you consider yourself generally healthy?
Are you able to attend appointments as required?
Are you comfortable with taking a new, experimental medicine?
Are you happy to have regular blood tests and health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, MK-7602, over several days. You might be asked to stay overnight at a clinic for some of the earlier doses so doctors can watch you closely. You'll likely receive different amounts of the medicine, as the study is looking at how varying doses affect your body. During your visits, you'll have regular check-ups, which will include blood tests and possibly other tests like checking your heart rate and blood pressure. These tests help the doctors understand how the medicine is working and whether it's causing any side effects. The study will last for a certain period, including follow-up visits after you've finished taking the medicine, to make sure everything is okay.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to scientific knowledge that could lead to new treatments for malaria, and receiving careful medical attention throughout your participation. However, there are also potential risks involved, mainly related to side effects from the new medicine, which could range from mild to more serious. You will be closely monitored for any reactions. Remember, you can choose to leave 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
Belgium

Common questions

What is malaria?

Malaria is a serious disease caused by parasites and spread through the bites of infected mosquitoes, leading to symptoms like fever, chills, and flu-like illness.

Why is this medicine being tested in healthy people first?

Testing in healthy people is the first step to make sure a new medicine is safe and to understand how the body handles it before giving it to people who are unwell.

What are 'side effects'?

Side effects are unwanted or unexpected reactions to a medicine, which can be mild like an upset stomach, or sometimes more serious.

Will I get 'placebo' in this study?

The study document lists 'Microcrystalline Cellulose, Lactose Monohydrate, Magnesium Stearate' as interventions, which are common inactive ingredients often used in placebos or as fillers in real medication. This suggests some participants might receive a placebo, but you would need to ask the study team for clarity on this for your specific group.

What does 'Phase I' mean?

Phase I is the earliest stage of human testing for a new medicine, focusing on checking its safety, how well people tolerate it, and how the body processes it.