A randomized, double-blind, single-center, 2-period cross-over Phase I study to assess the tolerability, safety and pharmacokinetics of antidepressant doses of oral ketamine hydrochloride prolonged release tablets (KET01) compared to intranasal esketamine in healthy male subjects
This study is an early-stage research project comparing a new tablet for depression, called KET01, with an already approved nasal spray, Spravato. Researchers want to understand how safe KET01 is, what side effects it might cause, and how the body absorbs and uses the medicine. They are specifically looking at antidepressant doses in healthy men. This helps them determine if the new tablet medicine could be a good option for treating depression in the future. The study involves giving participants either a dose of the new tablet, the nasal spray, or harmless dummy versions of each, and carefully monitoring their reactions and how the medication works in their bodies.
At a glance
What is this study about?
This study is an important first step in developing new treatments for depression. It's called a 'Phase I' study, which means it's one of the earliest stages of testing a new medicine. Think of it like a safety check. Researchers are giving a new tablet, called KET01, to healthy adult men. They want to see if the tablet is safe, how their bodies react to it, and how it compares to an existing treatment for depression called Spravato, which is a nasal spray. This isn't about treating depression yet, but about gathering crucial information before moving on to studies with people who actually have depression.
The main goal is to understand how the new tablet medicine works inside the body. This involves looking at how much of the medicine gets into the bloodstream, how long it stays there, and how the body breaks it down. They will also be carefully watching for any side effects or unexpected reactions. By doing this in healthy people first, they can get a clear picture of the medicine's basic properties without other health conditions making it complicated.
Ultimately, the information gathered from this study will help decide if KET01 is promising enough to be tested further. If it proves safe and shows good results in terms of how the body handles it, then it might eventually go on to bigger studies with people who have depression, to see if it can truly help improve their symptoms. It’s all part of the careful process of bringing new medications to those who need them.
Key takeaways
- Tests a new depression tablet (KET01) vs. an existing nasal spray (Spravato).
- Focuses on safety and how the medicine works in the body.
- Only healthy adult men can participate.
- It's an early-stage study, not a depression treatment trial.
- Your health will be closely monitored during the study.
Who may be eligible?
To join this study, you must be a male adult. You need to be at least 18 years old – there's no upper age limit, meaning older men can also take part. This study is specifically looking for healthy volunteers, so you shouldn't have any major medical conditions.
As it's an early safety study, participants usually need to be in generally good health. This means you shouldn't have any serious illnesses, or be taking medications that might interfere with the study drugs. Researchers will review your medical history and do some health checks to make sure it's safe for you to participate.
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 of age or older?
- Are you male?
- Are you generally in good health?
- Do you not have any major ongoing medical conditions?
What does participation involve?
If you take part in this study, you would receive either the new KET01 tablet, the Spravato nasal spray, or a placebo (a dummy treament with no active medicine). Because it's a 'cross-over' study, you might receive different treatments at different times during the study. This means you will spend time living at the study centre for a couple of separate periods.
During your stays, medical staff will frequently check your health, take blood and urine samples, and ask about how you are feeling and any side effects. You'll also likely have regular check-ups after each treatment period. The exact number of visits, tests, and the total time you'd spend in the study will be explained in detail by the research team.
Potential risks and benefits
Locations (1)
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Common questions
What is KET01?
KET01 is a new tablet medicine being developed to treat depression. This study is one of the first times it's being tested in people.
What is Spravato?
Spravato is a nasal spray that is already approved and used to treat certain types of depression.
Why is this study only for men?
Early studies (Phase I) sometimes focus on a specific group, like healthy men, to get a clear understanding of the new medicine's basic effects before expanding to other groups.
Is this study actually treating depression?
No, this study is about safety and how the body handles the medicine in healthy volunteers, not about treating depression symptoms themselves. It's an early step to see if the medicine is safe enough to be studied in people with depression later on.
What does 'pharmacokinetics' mean?
It's a scientific term that means how the body affects the medicine – how it's absorbed, distributed, broken down, and removed from the body.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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