Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

C4671052- A Phase 1, Randomized, Fixed Sequence, Multiple-Dose, Open-Label Study to Estimate the Effect of Nirmatrelvir (PF-07321332)/Ritonavir on Rosuvastatin Pharmacokinetics in Healthy Adult Participants

This research is a Phase 1 study, meaning it's one of the first human trials to look closely at how a new combination therapy for COVID-19 (Nirmatrelvir/Ritonavir, sometimes called Paxlovid) interacts with a widely used cholesterol-lowering medication called rosuvastatin (known as Crestor). We want to find out if taking these two medicines together changes how much rosuvastatin stays in your body and how quickly it's removed. This is important because knowing how medicines interact helps doctors prescribe them safely. This study involves healthy adults and aims to understand these drug interactions without testing if the medicines treat any illness.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

24 May 2023

coronavirus disease 2019 (COVID-19)

What is this study about?

Imagine your body as a finely tuned machine that processes medicines. When you take a pill, your body absorbs it, uses it, and then gets rid of it. This study is like a detective story, trying to figure out if one medicine (Nirmatrelvir/Ritonavir, a treatment for COVID-19) affects how another very common medicine (rosuvastatin, often used for high cholesterol) is handled by your body.

Specifically, researchers want to see if taking the COVID-19 medicine changes the levels of rosuvastatin in your blood. If levels go up too much, it could lead to side effects; if they go down too much, the medicine might not work as well. Understanding these interactions is incredibly important for doctors to prescribe medicines safely and effectively, especially for people who might need both treatments at the same time.

This is an early-stage study, called 'Phase 1'. It focuses purely on how the medicines behave in the body, rather than whether they treat a specific illness. This kind of research in healthy volunteers helps scientists gather crucial safety information before these drug combinations are given to people who are unwell.

Key takeaways

This study investigates how COVID-19 treatment interacts with cholesterol medication.
It aims to ensure medicines can be taken safely together.
Participation involves taking both medications and having regular blood tests.
Only healthy adults are eligible to join this research.
Your involvement contributes valuable information to medical science.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old, as there's no upper age limit. Both men and women can take part.

Because this study is about how medicines interact with each other, you'd need to be generally healthy and not have any serious ongoing medical conditions. The goal is to see how the medicines act in a 'typical' healthy person.

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 old or older?
Are you generally healthy?
Are you able to attend several clinic visits?
Are you comfortable with having blood samples taken?
Are you willing to take specific study medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given both the COVID-19 medicine (Nirmatrelvir/Ritonavir) and the cholesterol-lowering medicine (rosuvastatin) at different times, following a set schedule. You'll likely have several visits to the clinic, where doctors and nurses will take blood samples to measure the levels of rosuvastatin in your body. They'll also check your vital signs (like blood pressure and heart rate) and do other tests to make sure you're doing well. You'll also be asked about any side effects you might experience. The total duration of your participation, from your first visit to your last follow-up, would be explained to you in detail by the study team.

Potential risks and benefits

The main benefit of taking part in this study is contributing to medical knowledge that could help many people in the future, by making sure medicines can be prescribed more safely. You might also receive careful medical monitoring during the study. However, like all medicines, both Nirmatrelvir/Ritonavir and rosuvastatin can have side effects, which the study team will explain to you. There's also a small risk involved with blood tests and other procedures. Remember, participating is entirely voluntary, and you have the right 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.

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Unverified
Belgium

Common questions

What is the main purpose of this study?

The main purpose is to see how a new COVID-19 medicine affects the way your body handles a common cholesterol-lowering drug (rosuvastatin).

Who can take part in this study?

Healthy adults aged 18 and over, both men and women, can take part.

What medicines will I be given if I join?

You will be given the COVID-19 medicine (Nirmatrelvir/Ritonavir) and the cholesterol-lowering medicine (rosuvastatin, or Crestor) at different times.

Will this study help me if I have COVID-19 or high cholesterol?

This study is not designed to treat illness; it's about understanding how the medicines interact in healthy people. It helps gather information for future safe prescribing.

What does a 'Phase 1' study mean?

It means this is one of the first times these specific drug interactions are being studied in humans, focusing on how the body handles the medicines.