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Safety, Tolerability and Pharmacokinetics of Single Oral Dose of MK-1403 and Famotidine in Healthy Male Participants with Atherosclerosis

Registered drug

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What is this trial about?

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

The study looks at a condition called Atherosclerosis, which is a buildup of fatty deposits in the arteries that can restrict blood flow. The medication being tested is an oral capsule containing the experimental drug MK-1403. The main goal is to see whether a single dose of this drug is safe and well‑tolerated in healthy men.

Participants will receive either the test capsule or a matching inactive tablet (placebo) and will stay for a short period for observation. Blood samples will be taken at several time points to measure the drug’s pharmacokinetics, meaning how quickly it is absorbed, how high the level becomes in the blood, and how long it stays in the body. Throughout the visit, any side effects (called adverse events) and any reasons for stopping the medication will be recorded.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Arrival at the clinic
On the day of the study you arrive at the clinic and confirm your identity. you are asked to confirm that you have fasted as instructed and that you have not taken any prohibited medicines.
The staff records basic vital signs such as blood pressure and heart rate.
Step 2
Baseline assessments
A small amount of blood is drawn to establish baseline laboratory values.
The information collected will be used later to compare changes after the study medication is taken.
Step 3
Pre‑medication (if required)
Some participants receive a single oral dose of famotidine 20 mg film‑coated tablet. the tablet is swallowed with water about thirty minutes before the study drug.
famotidine is a medication that reduces stomach acid and is used in this study to help assess the effect of the study drug on the body.
Step 4
Administration of the study drug
You are given one hard capsule containing either mk‑1403 240 mg or a matching placebo. the capsule is taken orally with a glass of water.
The capsule is a single dose; no additional doses are taken during the study.
Step 5
Observation and blood sampling
After taking the capsule you remain in the clinic for a period of observation. during this time a series of blood samples are collected to measure the amount of mk‑1403 in the bloodstream.
The timing of the samples follows a schedule defined by the study protocol, covering the early period after dosing and later time points up to at least 24 hours.
Step 6
Final assessments and discharge
Once the last required blood sample is taken, vital signs are checked again.
You receive written instructions on what symptoms to watch for and how to report any possible adverse event.
Step 7
Follow‑up visit
A follow‑up visit or telephone contact is scheduled a few days after the study day to ask about any delayed symptoms or side effects.
The follow‑up ensures that any late‑occurring adverse events are recorded.

Who can join the trial?

3 criteria

Assigned male sex at birth and aged between 18 and 55 years, inclusive.
Must agree to use contraception (methods to prevent pregnancy) during the study unless they are confirmed to be azoospermic (having no sperm in the semen) or choose to remain abstinent (not having sexual activity) throughout the intervention period and for 7 days after the last dose of MK-1403.
Must be a healthy volunteer, meaning they do not have significant medical problems that could affect the study.

Who cannot join the trial?

4 criteria

Clinically significant past problems with hormone (endocrine) glands, digestion (gastrointestinal) system, heart and blood vessels (cardiovascular), blood (hematological), liver (hepatic), immune system (immunological), kidneys (renal), lungs (respiratory), urinary or reproductive organs (genitourinary), or serious brain or nerve disorders (major neurological) such as stroke or ongoing seizures.
A past diagnosis of cancer (also called malignancy, which means a disease where abnormal cells grow uncontrolled).
Having had a major surgery within the last 4 weeks (about one month) before the first study visit.
Having received a live vaccination (a vaccine that contains a weakened form of the germ) within the last 1 month before the first study visit.

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Investigated drugs

MK-1403
is an experimental medicine being studied for the first time in humans. In this trial participants take a hard capsule that contains the drug. The purpose of giving MK-1403 is to see if a single oral dose is safe, how well people can tolerate it, and how the body absorbs and processes the compound. Researchers will closely monitor any side effects and measure the drug levels in the blood to understand its behavior in the body.
Famotidine
is a well‑known medicine that lowers stomach acid. In this study it is given as a film‑coated tablet. The drug is included to help researchers compare the safety and how the body handles a familiar medication with the new experimental drug. Participants will be observed for any reactions, and the drug’s absorption will be measured as part of the overall safety assessment.

Famotidine

What is already known about the treatment

MK-1403
This investigational drug is given as a hard capsule taken by mouth, with a single dose of 240 mg in the study. It is currently not approved and is being tested in early clinical trials to assess safety and how it behaves in the body. The drug is intended to help treat atherosclerosis by influencing the way the body handles cholesterol and other fats. It belongs to the class of experimental oral lipid‑modifying agents.
Famotidine
This medication is supplied as a 20 mg film‑coated tablet that is swallowed orally. It is an approved medicine widely used to lower stomach acid and treat conditions such as ulcers and heartburn. Famotidine works by blocking H2 receptors in the stomach lining, which reduces the amount of acid produced. It is classified as an H2‑receptor antagonist, a type of acid‑reducing drug.

Investigated diseases

Atherosclerosis - Atherosclerosis is a condition in which fatty deposits build up on the inner walls of arteries. Over time these deposits harden and form plaques that narrow the vessel lumen. The narrowing reduces blood flow to organs and tissues, which can cause symptoms such as chest discomfort or leg pain during activity. As plaques grow, they may become unstable and break apart, further limiting circulation.