Not recruiting

A study to evaluate the safety of MK-1403 in healthy men for the treatment of atherosclerosis

Verified siteInvestigational

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What is this trial about?

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

This study focuses on Atherosclerosis, a condition where plaque builds up inside the arteries, which are the blood vessels that carry blood throughout the body. The purpose of the study is to evaluate the safety and how well the body handles a single dose of the drug MK-1403. Participants may receive either the active drug or a placebo, which is an inactive substance.

The treatment involves taking MK-1403 in the form of an oral capsule, which is a pill taken by mouth. During the study, researchers will monitor pharmacokinetics, which refers to how the body absorbs, distributes, processes, and eliminates a medication over time. This process helps determine how much of the substance stays in the blood and how long it remains active in the system.

The research process

The trial runs in 1 step.

Step 1
Administration of the study medication
A single dose of mk-1403, which is the test medication, will be taken by mouth in the form of a hard capsule.
The dose of mk-1403 is 300 mg (milligrams).
It is possible that mk-1403 will be administered with an additive, which is a substance added to the medication.
Alternatively, a placebo, which is a substance with no active medicine, may be administered instead of the test medication.

Who can join the trial?

5 criteria

You must be a person who was assigned male at birth.
You must be between 18 and 45 years old.
You must be a healthy volunteer, which means you do not have any underlying health problems.
You must agree to use contraception (methods used to prevent pregnancy, such as condoms) unless it is confirmed that you are azoospermic (a condition where there are no sperm in the semen).
Alternatively, you must agree to remain abstinent (not having sexual intercourse) during the time you are taking the study medication and for 7 days after your last dose.

Who cannot join the trial?

4 criteria

You have a history of important problems or diseases in your endocrine system (the glands that produce hormones), gastrointestinal tract (the digestive system), cardiovascular system (the heart and blood vessels), hematological system (blood and blood-forming tissues), hepatic system (the liver), immunological system (the body's immune system), renal system (the kidneys), respiratory system (the lungs and breathing), genitourinary system (the urinary tract and reproductive organs), or neurological system (the brain and nerves, including stroke or long-term seizures).
You have a history of cancer, which is a disease where abnormal cells grow uncontrollably.
You have had a major surgery in the 4 weeks before your first study visit.
You have received a live vaccination, which is a type of vaccine that uses a weakened version of a germ, within 1 month before your first study visit.

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Verified sites

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Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

Trial locations

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Investigated drugs

MK-1403 is an experimental medication being studied to see how safe it is and how the body processes it when taken by mouth in a single dose.

What is already known about the treatment

MK-1403 - This investigational drug is taken by mouth in the form of a hard capsule. It is currently being studied in clinical trials and is not yet available for general medical use. This medication is being developed to treat atherosclerosis, a condition where plaque builds up in the arteries, by working at a molecular level to influence specific biological processes related to heart health. It is classified as an experimental therapeutic agent for cardiovascular diseases.

Investigated diseases

Atherosclerosis - This condition involves the buildup of fats, cholesterol, and other substances in and on the artery walls. These accumulations form deposits known as plaques. Over time, these plaques can cause the arteries to narrow and harden. This process restricts the flow of blood and oxygen to various parts of the body. As the condition advances, the plaques may grow larger or cause the vessel walls to lose their flexibility.