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A study of the effects of nirmatrelvir, ritonavir, and rosuvastatin in healthy adult participants

Registered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to evaluate how the medicine nirmatrelvir/ritonavir affects the way the body processes rosuvastatin. The research focuses on the interaction between these medications in healthy individuals. Nirmatrelvir/ritonavir is an antiviral treatment used for COVID-19, which is the disease caused by the coronavirus. Rosuvastatin is a medication commonly used to manage cholesterol levels.

During the study, participants will take multiple doses of nirmatrelvir/ritonavir. After these doses, a single oral dose of rosuvastatin will be administered. Researchers will then monitor the pharmacokinetics, which refers to how a drug moves through the body, including how it is absorbed, distributed, and eliminated. This process is measured by looking at the concentration of the medicine in the blood over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of background medication
Take a single 10 mg dose of rosuvastatin (crestor) by mouth. rosuvastatin is a medication used to manage cholesterol levels.
Take a 200 mg dose of ritonavir (norvir) by mouth. ritonavir is a medication used in combination with other drugs.
Step 2
Administration of study medication
Take multiple doses of nirmatrelvir (600 mg) combined with ritonavir (200 mg) by mouth. nirmatrelvir is the test medicine being studied.
Step 3
Monitoring and testing
Undergo regular monitoring of vital signs, which include measurements such as blood pressure and heart rate.
Provide samples for laboratory tests to monitor health and measure how the rosuvastatin moves through the blood after the medications are taken.
Be monitored for any adverse events, which are any side effects or unexpected health changes occurring during the study.

Who can join the trial?

7 criteria

Both men and women who are 18 years of age or older can join the study.
Participants must be overtly healthy, meaning they show no signs of illness during a medical evaluation, which includes a review of their medical history (past health records), a physical examination (a doctor's check-up), laboratory tests (blood or urine tests), vital signs (such as blood pressure and heart rate), and a 12-lead electrocardiogram, which is a test that records the electrical activity of the heart.
Participants must be willing and able to follow all scheduled visits, the treatment plan, all required tests, and specific lifestyle considerations required by the study.
Women who are of childbearing age must have a negative pregnancy test.
Participants must have a body mass index (BMI), which is a measure of body fat based on height and weight, between 16 and 32 kg/m2.
Participants must weigh more than 50 kg (110 lb).
Participants must be able to provide signed informed consent, which is a formal agreement to participate in the study after understanding all the details, rules, and restrictions.

Who cannot join the trial?

10 criteria

You cannot join if you have a positive test for SARS-CoV-2, which is the virus that causes COVID-19, or if you have received a COVID-19 vaccine in the 7 days before starting or plan to get one during the study.
You are excluded if you have or have had a significant problem with your blood (hematological), kidneys (renal), hormones (endocrine), lungs (pulmonary), stomach or intestines (gastrointestinal), heart (cardiovascular), liver (hepatic), mental health (psychiatric), or nervous system (neurological).
You cannot participate if you have serious allergies, though minor seasonal allergies that do not require treatment are allowed.
You are excluded if you have had surgery that might change how your body absorbs medication, such as the removal of the stomach (gastrectomy) or the gallbladder (cholecystectomy).
You cannot join if you have a history of, or test positive for, HIV (a virus that affects the immune system), Hepatitis B, or Hepatitis C (viruses that affect the liver).
You are excluded if you have serious heart conditions that require treatment, such as a recent heart attack (acute myocardial infarction), unstable blood flow to the heart, or irregular heart rhythms (arrhythmias).
You cannot participate if you have certain heart structure problems, such as heart failure (where the heart cannot pump blood well enough), cardiomyopathy (disease of the heart muscle), or other structural issues.
You are excluded if you have any mental health conditions, including active or recent thoughts of self-harm or suicide (suicidal ideation).
You cannot join if you have any abnormal laboratory results or other health issues that make participating in the study risky or inappropriate.
You are excluded if the official instructions for rosuvastatin (the medication being studied) state that you would be at a higher risk of harm if you took it.

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Investigated drugs

Nirmatrelvir
is a medication being tested in this study to see how it affects other drugs in the body.
Ritonavir
is used in this study alongside the test medication to help it work effectively in the body.
Rosuvastatin
is a medication used to manage cholesterol levels, which is being monitored in this trial to see if the test medications change how it is processed by the body.

What is already known about the treatment

Nirmatrelvir
This medication is taken as an oral film-coated tablet and is currently used to treat COVID-19. It belongs to a group of drugs called protease inhibitors, which work by blocking a specific protein that the virus needs to multiply within the body. By stopping this protein from working, the medicine prevents the virus from spreading to more cells.
Rosuvastatin calcium
This medicine is an oral film-coated tablet used primarily to lower high cholesterol and prevent heart disease. It belongs to a class of drugs known as statins, which work by blocking a specific enzyme in the liver that the body uses to produce cholesterol. This process helps reduce the amount of bad cholesterol circulating in the bloodstream.
Ritonavir
This substance is administered as an oral film-coated tablet and is widely used in medical treatments to manage viral infections. It is classified as a protease inhibitor and works by interfering with the enzymes that viruses use to replicate. In certain combinations, it is also used to help other antiviral medications stay in the body longer by slowing down how quickly they are broken down.

Investigated diseases

coronavirus disease 2019 (COVID-19) - This is an infectious illness caused by a specific type of virus that affects the respiratory system. The infection typically begins when the virus enters the body through the nose, mouth, or eyes. Once inside, the virus can spread through the airways and settle in the lungs. Common symptoms often include fever, cough, and tiredness. The progression of the disease can vary significantly between different individuals.