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Safety, Tolerability and Pharmacokinetics of MK-7480 and Diltiazem Hydrochloride in Healthy Adult Male Participants for Non‑alcoholic Steatohepatitis

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What is this trial about?

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

The condition being investigated is Non-alcoholic steatohepatitis, a liver disease in which excess fat leads to inflammation and damage. The experimental medication is an oral tablet called MK-7480 given at a dose of 300 mg. In some parts of the study the standard heart medication Diltiazem hydrochloride is also taken to see if it changes how the new drug works, and a matching inert pill referred to as placebo is used for comparison.

The aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics of single, increasing doses of the test drug in healthy adult men. Participants receive one dose of the study tablet, sometimes after a meal and sometimes together with the heart medication, while others receive the inert pill. After dosing, participants are observed for any adverse events and have blood samples taken at several time points to measure how quickly the drug appears in the bloodstream, how high the levels become, and how long it stays in the body. The study follows each participant for a short period after the dose to complete these observations.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and enrollment

    You arrive at the study site after having agreed to take part. you sign the consent form and a study staff member records basic health information and conducts safety checks such as vital signs and a brief medical history.

    You receive instructions about the upcoming dose, including any fasting requirements and what to expect during the monitoring period.

  2. Step 2

    Dose administration day

    On the scheduled day you fast for at least eight hours unless you are assigned to the fed arm, in which case you eat a standardized meal before taking the medication.

    You swallow one mk-7480 tablet containing 300 mg of the study drug. the tablet is taken by mouth with a small amount of water.

    If you are part of the drug‑interaction group you also take one dose of diltiazem hydrochloride 240 mg orally at the same time. participants who receive placebo swallow an identical‑looking tablet that contains no active drug.

  3. Step 3

    Post‑dose monitoring and blood sampling

    After the dose you remain at the clinic for a continuous monitoring period of up to 24 hours.

    A series of blood samples is collected at predefined times (for example, at 0.5, 1, 2, 4, 8, 12, and 24 hours) to measure the concentration of mk-7480 in your plasma.

    Study staff observes you for any signs of discomfort, side effects, or other adverse events and records your observations.

  4. Step 4

    Final assessment and discharge

    At the end of the 24‑hour monitoring period a final blood sample is taken and a brief safety check is performed.

    You are given a summary of the visit, instructions for reporting any symptoms that appear later, and you are discharged from the clinic.

Who can join the trial?

5 criteria

  • Be in good health – you should feel well and have no serious medical problems.
  • Have a Body Mass Index (BMI) between 18 and 32 kg/m². BMI is a number that compares your weight to your height to show if you are underweight, normal weight, overweight, or obese.
  • Be a male who was assigned male sex at birth.
  • Do not have regular penile‑vaginal intercourse as your usual lifestyle, and agree to stay abstinent or use a study‑approved method of birth control (contraception) during the trial.
  • Be willing to follow all study rules and restrictions.

Who cannot join the trial?

11 criteria

  • You have had any serious problems with your endocrine (hormone) system, gastrointestinal (digestive) tract, cardiovascular (heart and blood vessels) system, blood, liver (hepatic), immune (immunological) system, kidneys (renal), lungs (respiratory), urinary or reproductive organs (genitourinary), or major brain or nerve disorders such as stroke or ongoing seizures.
  • You regularly drink more than six servings of coffee, tea, soda, energy drinks, or other caffeinated beverages each day (one serving ≈ 120 mg of caffeine).
  • You regularly use cannabis, any illegal (illicit) drugs, or have misused drugs or alcohol within the past 12 months.
  • You have ever been diagnosed with cancer (malignancy).
  • You test positive for hepatitis B, hepatitis C, or HIV (human immunodeficiency virus).
  • You had a major surgery or gave/lost about one unit of blood (≈ 500 mL) within the four weeks before the screening visit.
  • You received a non‑live vaccine (a vaccine that does not contain a living virus) within 14 days before the study, or plan to receive one within 30 days after the study, except for COVID‑19 or inactivated flu vaccines, which must be given at least 72 hours before or 48 hours after the study dose.
  • You cannot stop taking any medicines, over‑the‑counter drugs, or herbal supplements for at least four weeks before the first dose and for the entire study period.
  • You participated in another clinical trial within the past four weeks.
  • You smoke cigarettes or use nicotine products (such as patches or e‑cigarettes) within the last three months.
  • You drink more than three alcoholic beverages per day (one serving ≈ 12 oz beer, 4 oz wine, or 1 oz distilled spirit).
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Investigated drugs

  • MK-7480

    is an experimental medicine being studied for the first time in people. It is taken as a tablet by mouth. In this trial the researchers are giving single increasing amounts of the tablet to healthy volunteers to see if it is safe, how well people can tolerate it, and how the drug moves through the body.

  • Diltiazem

    is a medicine that is already used to treat heart problems such as high blood pressure and irregular heartbeats. In this study it is also given as a tablet taken by mouth. The purpose of including it is to compare its safety and how the body handles it with the new experimental drug.

What is already known about the treatment

  • MK-7480

    This investigational drug is taken as a 300 mg oral tablet and is being studied in early‑phase clinical trials for non‑alcoholic steatohepatitis. It is not yet approved and currently exists only in research literature as a new candidate. The main aim is to improve liver health by influencing metabolic pathways that control fat buildup and inflammation. MK‑7480 works by activating a specific nuclear receptor that regulates gene activity related to bile acid and lipid metabolism, placing it in the class of selective nuclear receptor modulators.

  • Diltiazem Hydrochloride

    Diltiazem is given as an oral tablet, commonly in doses such as 240 mg, and is an approved medication widely used worldwide. It is listed in medical references for treating high blood pressure, chest pain (angina), and certain irregular heart rhythms. The drug relaxes blood vessels and slows heart activity by blocking calcium entry into heart and smooth‑muscle cells. Because of this action, it belongs to the pharmacological class of nondihydropyridine calcium‑channel blockers.

Investigated diseases

Non-alcoholic steatohepatitis - Non-alcoholic steatohepatitis is a condition in which excess fat accumulates in the liver of people who consume little or no alcohol, accompanied by inflammation and damage to liver cells. The inflammation can trigger the formation of scar tissue, causing the liver to become fibrotic. As fibrosis progresses, the liver becomes less able to perform its normal metabolic functions. Over time, this can lead to increasingly stiff liver tissue and reduced overall liver health. In advanced stages, extensive scarring may develop, further impairing liver function.
Trial detailsLast updated 5 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505138-88-00Protocol codeMK-7480-001Estimated enrolment36 patientsSponsorMerck Sharp & Dohme LLC

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