CompletedPhase IInterventional

A study in healthy men of the absorption of radiolabelled [14C]LTG-001, how the body breaks it down, and how quickly the body gets rid of it

This study is looking for healthy men to test a new pain medication called LTG-001. Current pain medicines don't always work and can have unwanted side effects, so this new medicine aims to offer a better option by blocking pain signals in the body. In this study, we'll give volunteers a single dose of the medicine, which contains a tiny amount of radioactivity to help us track it. We'll then collect blood, urine, and stool samples over several weeks to understand how the body absorbs, breaks down, and removes the medicine. We'll also keep a close eye out for any side effects to learn more about its safety. Your participation helps us develop better pain treatments for people in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Latigo Biotherapeutics, Inc.

Enrolment target

Start

09 Oct 2025

Estimated completion

26 Nov 2025

This trial is in healthy volunteers

What is this study about?

Imagine your body sends pain signals to your brain through special pathways. This study is testing a new medicine, LTG-001, which aims to help by blocking some of these pain messages. This could lead to a new way to treat both short-term pain (like after an injury) and long-lasting pain that continues for months.

At the moment, many pain medicines have side effects or don't work for everyone. So, there's a real need for new and better treatments. This study is an important first step. We're giving the new medicine to healthy volunteers, not people with pain, to understand how it works in the body from a basic level. This involves giving a single dose of the medicine containing a very small amount of radioactivity – don't worry, this is safe and helps us follow the medicine's journey inside you. By understanding how your body handles this medicine, we can learn important things about its safety and how it might work for patients later on.

This early research is critical for developing new medicines. Although you won't get any direct medical benefit, your contribution will help scientists gather vital information. This information is then used to decide if the medicine can move forward to bigger studies involving people who suffer from pain. Your involvement helps pave the way for potentially better and safer pain relief for many people in the future.

Key takeaways

Testing a new pain medication (LTG-001) in healthy men.
Aims to understand how the body uses, breaks down, and removes the medicine.
Involves a single dose, clinic stay (up to 21 nights), blood, urine, and stool samples.
Participation helps develop future pain treatments; no direct benefit for volunteers.
Low risk from radiation; careful monitoring for side effects.

Who may be eligible?

To join this study, we are looking for healthy men between the ages of 30 and 65. You'll need to be in good general health, as confirmed by our doctors after a check-up, and have a body mass index (BMI) between 18 and 35. You also need to have regular bowel movements.

You cannot join if you have ever had a serious bad reaction or allergy to any medicine, or if you have certain health problems like serious heart, kidney, liver, skin, breathing, stomach, or bowel conditions (such as painful ulcers or Crohn's Disease). If you've had major stomach surgery (other than appendix removal or hernia repair more than a year ago), or if you've recently had severe diarrhoea or constipation, you also won't be able to take part. We also need to make sure you have suitable veins for blood tests.

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 a man aged between 30 and 65 years old?
Do you consider yourself generally healthy?
Do you have a healthy weight (BMI between 18 and 35)?
Do you have regular bowel movements?
Have you had any serious allergies or major stomach problems in the past?
Are your veins generally easy for blood tests?

Answer every question to see your result.

What does participation involve?

If you join, you will receive a single capsule of the study medicine by mouth. You'll stay at the clinic for up to 21 nights. Over a period of at least 14 days, you'll have many blood samples taken, and you'll collect all your urine and stool samples. This helps us track the medicine. The whole study, including follow-up visits, will take up to 7 weeks. You'll also need to follow certain rules, like fasting (not eating or drinking, except water, for some periods) and restrictions on donating sperm or fathering a child during the study.

Potential risks and benefits

While you won't get direct medical benefits from taking part, your contribution is very important for developing new pain treatments that could help many people in the future. As with any medicine, there's a chance of side effects, as this medicine is new. We'll monitor you very closely to look for any issues. You'll be exposed to a very small amount of radiation, similar to about four days of natural background radiation in the UK, which is considered very safe. We'll perform health checks which might uncover a medical issue you didn't know about, and we would share important findings with your GP. You can always decide to leave the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quotient Sciences Limited
City only
Nottingham, England

Common questions

Why is this study only for men?

Studies sometimes start with one gender to understand the medicine's basic behaviour before including a wider group. This helps simplify the early stages of testing.

What does 'radiolabelled' medicine mean?

It means the medicine contains a tiny, safe amount of a special substance (like Carbon-14) that allows us to track exactly where it goes and how it's used in your body. It's like putting a tiny, harmless tracker on it.

Will I feel any pain relief from taking the medicine?

No, this study is about understanding how the medicine works in healthy people, not how it treats pain. You are not expected to feel any pain relief.

Will I be paid for taking part?

Yes, you will receive payment for your time, any inconvenience, and to cover your travel and other expenses. This payment will be fair and approved by an ethics committee.

What happens if I change my mind during the study?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Neil Singla

clinicaltrials@latigobio.com +1 (0)805 716 2927 Official trial record

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