RecruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

This study is looking into a new medicine called LTP001. It has two main parts. In the first part (Part A), healthy volunteers will take the medicine. This helps doctors learn if LTP001 is safe, how the body handles it, and if there are any side effects. In the second part (Part B), people who have a serious lung condition called Pulmonary Arterial Hypertension (PAH) will receive the medicine. The aim here is to see if LTP001 can help their condition and if it's safe for them. After that, there will be a phase to keep checking on their safety. The study involves both males and females aged 18 to 100 years.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

232

Start

24 Oct 2024

Estimated completion

31 Dec 2028

Healthy Volunteers, Pulmonary Arterial Hypertension

What is this study about?

This study is designed to learn more about a new medication called LTP001. It's being tested in stages to make sure it's safe and to understand how it works in the body. Developing new medicines involves careful steps, and this study is an important part of that process.

The study has two parts. The first part, called Part A, will involve healthy volunteers. Healthy people taking part helps researchers understand how the medicine behaves in the body when there are no other health conditions. They'll be checking things like how much medicine gets into the blood, how long it stays there, and if there are any side effects. This step is really important for safety before the medicine is given to people who are unwell.

The second part, called Part B, will include individuals who have Pulmonary Arterial Hypertension (PAH). PAH is a serious condition that affects the blood vessels in the lungs. In this part of the study, researchers want to see if LTP001 can improve the condition of people with PAH and if it continues to be safe for them. Participants in Part B will already be receiving their usual PAH treatments, and LTP001 will be given in addition to these. The study also includes a safety follow-up period to keep an eye on participants after they've finished taking the study medicine.

Key takeaways

New medicine LTP001 is being studied for safety and how it works.
First part is for healthy volunteers, second part for people with PAH.
Compares LTP001 to a placebo (dummy medicine).
You'll have regular medical checks and tests if you take part.
Participation is voluntary; you can withdraw at any time.

Who may be eligible?

This study is open to both men and women between the ages of 18 and 100.

For Part A, if you are a healthy adult, you might be able to join. However, you cannot have any major heart problems or other serious health issues that could affect how your body handles the medicine or put you at risk during the study. If you are female, you must not be able to have children (for example, if you've been through menopause or had a hysterectomy).

For Part B, you must have a confirmed diagnosis of PAH and be on stable doses of your usual PAH medicines. You'll need to be able to walk between 150 and 450 metres in 6 minutes. You cannot have any medical conditions that would put you at higher risk in the study. Women who could become pregnant must use very effective birth control. Men must agree to use a condom during sex while taking the study medicine and for a day after stopping it. You also can't have had a bad reaction to similar medicines before.

Quick self-check

Are you between 18 and 100 years old?
If you have PAH, are you on stable doses of your usual PAH medicines?
Do you have any serious heart conditions or other major health problems?
If you are female, can you become pregnant?
If male and sexually active, are you willing to use a condom during the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will be given either the new medicine, LTP001, or a 'placebo'. A placebo looks like the real medicine but contains no active ingredients; this helps researchers compare the effects of the new medicine fairly. You won't know if you're getting the active medicine or the placebo.

You will have regular visits to the clinic for check-ups. These visits will involve various assessments, such as blood tests, heart checks (ECG), and physical examinations to make sure you're doing well and to see how the medicine is affecting your body. For those with PAH, your walking ability may also be assessed.

The total length of time you'll be involved in the study will vary depending on which part you join, but it will involve taking the study medication for a period, followed by regular check-ups. You will be told the exact duration before you agree to take part.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help your condition if you have PAH. You'll also receive careful medical monitoring. However, there are also potential risks; you might experience side effects from the study medicine, or for those in Part B, the medicine might not help your PAH. The placebo also means you might not get the active treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (85)

Arizona Pulmonary Specialists Ltd
Scottsdale, United States· Recruiting
UC Irvine Medical Center
Orange, United States· Recruiting
Stanford Medical Center
Stanford, United States· Recruiting
Univ Colorado Hospital
Aurora, United States· Recruiting
Central Florida Pulmonary Group
Orlando, United States· Recruiting
University of South Florida
Tampa, United States· Recruiting
Emory University School of Medicine
Atlanta, United States· Recruiting
U of Kansas Medical Center
Kansas City, United States· Recruiting
Norton Infectious Diseases Specialists
Louisville, United States· Recruiting
Tufts Medical Center
Boston, United States· Recruiting
Lahey Hospital and Medical Center
Burlington, United States· Recruiting
Sky Integrative Medical Center SKYCRNG PPDS
Ridgeland, United States· Recruiting

+73 more sites — see the official record for the full list.

Common questions

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a serious condition where the blood vessels in your lungs become narrowed, making it harder for your heart to pump blood through them. This can cause symptoms like shortness of breath and tiredness.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but doesn't contain any active drug. Giving some people a placebo helps researchers fairly compare the new medicine's effects against doing nothing extra.

Will I know if I'm getting the actual medicine or a placebo?

No, during the study, neither you nor your study doctor will know if you are receiving the active medicine or the placebo. This helps prevent bias in the results.

How long will the study last?

The total length of time you would be involved in the study will be explained in detail by the study team. It will include time taking the medicine and follow-up appointments.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your future medical care.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

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