A study to evaluate how JNJ-77242113 is absorbed by the body in healthy participants for the treatment of inflammatory diseases.

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What is this study about?

This study aims to investigate how the body absorbs a new drug called JNJ-77242113. The research focuses on inflammatory diseases, which are conditions where the body’s immune system causes swelling and irritation in various parts of the body. Specifically, the study looks at different versions of a film-coated tablet, which is a pill covered with a thin layer to make it easier to swallow or to control how it dissolves. The investigation will compare an immediate-release formulation, meaning the medicine is released into the body quickly after being swallowed, with a previous version of the same medicine.

The study involves a crossover design, which means participants will receive different versions of the medication at different times during the trial. This approach allows for a comparison of how the body processes each version. Additionally, the study will evaluate the food effect, which refers to how eating meals might change the way the medicine is absorbed into the bloodstream. All participants will take the medication through oral use, meaning the tablets are swallowed by mouth.

Who Can Join the Study?

Both men and women can participate if they are between 18 and 60 years old at the time of the initial screening.
Participants must be considered healthy based on a physical exam, a review of their medical history, and their vital signs (such as blood pressure and pulse).
Participants must have a normal 12-lead ECG, which is a test that records the electrical activity of the heart to ensure it is working correctly.
Participants must have normal results from clinical laboratory tests, which are medical tests performed on blood or other body fluids to check overall health.
A person’s Body Mass Index (BMI), which is a measure of body fat based on height and weight, must be between 18.0 and 30.0.
Participants must weigh at least 50.0 kg (about 110 pounds).
Women who can become pregnant are not eligible; they must be postmenopausal (no longer having menstrual periods) or permanently sterile (unable to have children).

Who Cannot Join the Study?

Having a history of or currently suffering from any serious medical condition, such as cardiac arrhythmias (irregular heartbeats) or other heart diseases.
Having hematologic disease (disorders that affect the blood) or coagulation disorders (conditions that affect how your blood clots).
Having lipid abnormalities (unhealthy levels of fats, such as cholesterol, in your blood).
Having significant pulmonary disease (serious lung problems), including bronchospastic respiratory disease (conditions like asthma where the airways narrow and make breathing difficult).
Having diabetes mellitus (a condition where blood sugar levels are too high).
Having hepatic or renal insufficiency (problems with how the liver or kidneys function).
Having thyroid disease (conditions related to the thyroid gland that controls your body’s metabolism).
Having neurologic or psychiatric disease (conditions affecting the brain, nerves, or mental health).
Having an active infection (an illness caused by germs like bacteria or viruses).
Any other illness that the study doctor believes might prevent you from joining or might make the study results difficult to understand.
A history of malignancy (cancer) before the screening process began.
Known allergies, hypersensitivity (an exaggerated immune response), or intolerance to the study medicine or its excipients (the inactive ingredients used to make the pill).
A history of gastrointestinal disease (problems with the stomach or digestive tract).
A history of surgical resection (the medical removal of an organ or part of the body through surgery).

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Janssen Pharmaceutica	Antwerp	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.07.2023

Trial locations

JNJ-77242113 is an experimental medication being tested in this study to see how well the body absorbs it when taken as a tablet. The study compares different versions of this tablet to understand how quickly it enters the bloodstream and how food might affect its absorption.

Investigated diseases:

Inflammation

Inflammatory conditions – These are states where the body’s immune system reacts to perceived threats, causing swelling and redness in tissues. The process typically begins when the immune system sends specialized cells to a specific area to fight off potential harm. This response can cause local heat, pain, and physical changes in the affected part of the body. Over time, the immune response may become persistent or spread to different areas. The intensity and duration of these conditions can vary depending on the underlying cause.

Trial ID:

2023-504720-26-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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A study to evaluate how JNJ-77242113 is absorbed by the body in healthy participants for the treatment of inflammatory diseases.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?