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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Single Rising Dose Study of MK-1708 in Healthy Participants

This is a very early study (called Phase 1) that is looking at a new medicine called MK-1708 for the very first time in people. Researchers want to understand how different amounts (doses) of this drug affect healthy men. They will check how safe it is and how the body absorbs, uses, and gets rid of it. The main goal is to find a safe dose and learn more about the drug's effects. While this study is in healthy volunteers, it's a first step towards potentially helping people with serious conditions like motor neurone disease (known as Amyotrophic Lateral Sclerosis) and Alzheimer's disease in the future.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
24
Start
13 Oct 2023

What is this study about?

Imagine a new medicine is created in a lab. Before it can ever be given to patients, scientists need to find out if it's safe and how it works in the human body. That's exactly what this study is about. It's a very early-stage trial, often called 'Phase 1' or 'human pharmacology,' which means it's the first time people will be taking this specific drug, known as MK-1708.

The main purpose of this study is to give healthy volunteers different single doses of MK-1708. The research team will then carefully watch to see if the drug causes any side effects and how the body processes it. They'll be checking how much of the drug gets into the bloodstream, how long it stays there, and how it's eventually removed from the body. This helps them work out a safe dose for future studies.

Even though this study is with healthy people and not those who are unwell, the information gathered is incredibly important. It's a foundational step that could eventually lead to new treatments for serious illnesses like Amyotrophic Lateral Sclerosis (ALS), often called motor neurone disease, and Alzheimer's disease. By understanding how MK-1708 behaves, researchers can decide if it's safe and promising enough to move on to studies with patients who have these conditions.

Key takeaways

  • This is an early-stage study (Phase 1) testing a new drug, MK-1708.
  • It's the first time this drug is being given to people.
  • Only healthy men aged 18 and older can participate.
  • The main goals are to check the drug's safety and how the body handles it.
  • It's a step towards potentially helping people with conditions like motor neurone disease and Alzheimer's.
  • Participants will receive a single dose of the study drug.

Who may be eligible?

This study is looking for a very specific group of people to take part. To be considered, you must be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are also welcome to inquire.

Importantly, this particular study is only for men. Women are not able to participate in this specific trial.

Beyond age and sex, participants need to be in good overall health. This means the research team will do careful checks to make sure you don't have any serious ongoing medical conditions or other factors that might make taking the trial drug unsafe 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.

  1. Are you 18 years old or older?
  2. Are you male?
  3. Are you generally in good health?
  4. Are you fit enough for medical examinations and blood tests?
  5. Are you comfortable with receiving a new, untested drug?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit. This involves medical checks to ensure you are healthy enough and meet all the study requirements. If you qualify, you would then receive a single dose of the study drug, MK-1708. This would likely happen during a short stay at the clinic where doctors and nurses can monitor you closely for any reactions.

Throughout your participation, which includes the dose administration and follow-up, medical staff will conduct various assessments. These might include blood tests, urine tests, checking your blood pressure and heart rate, and asking you about how you are feeling. The total duration of your involvement, from the first screening to the final check-up, isn't specified but for a single-dose study, it usually involves a short stay and some follow-up visits.

Potential risks and benefits

Taking part in any study has potential aspects to consider. A potential benefit of this study is contributing to medical science, which could one day lead to new treatments for serious diseases. However, there is no direct personal health benefit for participants, as you would be healthy volunteers and not receive a treatment for a condition you have. Possible risks include side effects from the investigational drug MK-1708, which are currently unknown as this is the first time it's being given to humans. These side effects could range from mild to serious. Thorough medical checks will be done before and during the study to ensure your safety. You are free 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.
  • Unverified
    Belgium

Common questions

What is the study drug MK-1708?

It's a new medicine that is being tested for the very first time in people. Its full effects and safety are still being investigated.

Why are healthy people taking part?

In early-stage studies like this, healthy people help researchers understand how a new drug works in the body and if it's safe before giving it to patients with a disease.

What's a 'single rising dose' study?

It means participants will receive just one dose of the medicine, and different groups of volunteers will receive gradually higher doses to find a safe amount.

Will I get medication for motor neurone disease or Alzheimer's?

No, this study is about understanding the drug in healthy people. It's a very early step and not a treatment for those conditions.

Do I have to stay in the hospital?

For a study like this, you would likely need to stay at the clinic for a short period around the time you receive the drug so the team can monitor you closely.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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