A Study to Learn About the Study Medicine Called PF-07868489 in Healthy Adult People and in People With Pulmonary Arterial Hypertension
This research study is looking into a new medicine called PF-07868489. It aims to understand how safe it is and how it affects the body, both in healthy adults and in people who have a serious lung condition called Pulmonary Arterial Hypertension (PAH). PAH makes it hard for blood to flow through the lungs, causing shortness of breath and tiredness. The study has two main parts. The first part gives small doses of the medicine to healthy volunteers. The second part involves people with PAH taking the medicine over 24 weeks. Researchers will closely monitor participants to see if the medicine helps, how well it's tolerated, and if there are any side effects. This is a crucial step in developing new treatments for PAH.
At a glance
What is this study about?
This study is a research project designed to help us understand a new medicine called PF-07868489. The main goal is to find out if this medicine is safe and how it behaves in the body. We're looking at two groups of people: healthy adult volunteers and adults who have a specific lung condition called Pulmonary Arterial Hypertension (PAH). PAH is a serious illness where the blood vessels in the lungs become narrow, making it difficult for the heart to pump blood, which can lead to breathlessness and fatigue.
The study is divided into two main parts. In the first part, healthy adults will receive different, usually small, doses of the study medicine. This helps doctors learn how well the body handles the medicine and what happens to it once it's in the system. The second part focuses on people with PAH. They will either receive the study medicine or a placebo (an inactive substance that looks like the medicine) over approximately 24 weeks. This allows researchers to compare the effects of the medicine against not having it, helping them understand if it might be an effective treatment for PAH.
By taking part, volunteers help gather important information that could lead to new treatments. This is an early-stage study (Phase 1 and 2), which means it's one of the first times this medicine is being tested in humans. The information collected from this study will be used to decide if the medicine should be tested further in larger studies, moving closer to potentially becoming available to patients in the future.
Key takeaways
- This study is testing a new medicine, PF-07868489, for Pulmonary Arterial Hypertension (PAH).
- It aims to understand the medicine's safety and how it works in both healthy adults and those with PAH.
- Participation involves regular clinic visits, medical checks, and taking either the study medicine or a placebo.
- The study lasts about 24 weeks for people with PAH.
- You can stop participating at any time without affecting your medical care.
- This is an early-stage study, meaning the medicine's effectiveness is still being explored.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old. The requirements are slightly different depending on whether you're a healthy volunteer or someone with Pulmonary Arterial Hypertension (PAH).
If you're a healthy volunteer, you must be generally well with no significant long-term health problems like heart, kidney, or lung disease. Your weight should also be within certain limits. You shouldn't smoke more than 10 cigarettes a day or have a history of heavy smoking.
If you have PAH, you must have an official diagnosis of the condition and be on a stable dose of your usual PAH treatments. There are also specific tests related to your lung and heart function that need to meet certain levels. Similar to healthy volunteers, your weight needs to be within a specific range, and you shouldn't be a heavy smoker. We also can't include you if you've had major surgery recently or have other serious medical conditions that might interfere with the study.
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 between 18 and 65 years old?
- If healthy, do you have any major long-term health problems?
- If you have PAH, have you been officially diagnosed and are you on stable treatment?
- Are you able to attend regular clinic appointments?
- Do you smoke more than 10 cigarettes a day, or have you been a heavy smoker in the past?
What does participation involve?
If you decide to take part in this study, you will be carefully monitored by a team of doctors and nurses. The study involves regular visits to the clinic, where you will have various medical assessments. These might include physical examinations, blood tests, heart checks (like ECGs), and other specific tests related to your condition or the medicine.
You will be given either the study medicine, PF-07868489, or a placebo (a dummy medicine that looks the same). Neither you nor your study doctor will know which one you are receiving, which helps ensure the results are unbiased. You'll take the medication as instructed and keep records of how you're feeling and any side effects.
The healthy volunteer part of the study involves a single dose of the medicine. The PAH part of the study could last for about 24 weeks. Throughout your time in the study, there will be follow-up appointments to check your health and how you're responding to the treatment. You will be given more detailed information about travel and visit schedules if you are suitable for the study.
Potential risks and benefits
Locations (68)
- Anaheim Clinical Trials, LLCVerified postcodeAnaheim, United States
- UCI Health - Costa MesaVerified postcodeCosta Mesa, United States
- UCI Health Center for Innovative Health Therapies (CIHT)Verified postcodeOrange, United States
- University of California, Irvine Medical CenterVerified postcodeOrange, United States
- UC Davis Health Medical CenterVerified postcodeSacramento, United States
- University of California Davis HealthVerified postcodeSacramento, United States
- UCSF Health St. Mary's HospitalVerified postcodeSan Francisco, United States
- UCSF Helen Diller Medical Center at Parnassus HeightsVerified postcodeSan Francisco, United States
- University of Colorado Anschutz Medical CampusVerified postcodeAurora, United States
- Norton HospitalVerified postcodeLouisville, United States
- Norton Pulmonary SpecialistsVerified postcodeLouisville, United States
- Icahn school of medicine at Mount SinaiVerified postcodeNew York, United States
Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a serious lung condition where the blood vessels in the lungs become narrow and blocked, making it harder for blood to flow through. This causes the heart to work harder, leading to symptoms like shortness of breath and tiredness.
What is a 'placebo'?
A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. Giving some participants a placebo helps researchers compare the effects of the actual medicine more accurately.
Who is paying for this study?
This study is being sponsored by a pharmaceutical company called Pfizer, which is developing the medicine PF-07868489.
What does 'Phase 1' and 'Phase 2' mean?
Phase 1 studies are the first time a new medicine is tested in humans, usually a small group of healthy people, to check its safety. Phase 2 studies involve more patients and focus on how well the medicine works and its side effects.
Will I know if I'm getting the actual medicine or the placebo?
No, both you and your study doctor will not know whether you are receiving the study medicine or the placebo. This is to ensure the results are as fair and unbiased as possible.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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