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Multiple Ascending Dose Safety, Tolerability and Pharmacokinetics of MK-7602 in Healthy Volunteers for Malaria

Verified siteInvestigational

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What is this trial about?

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

Malaria is an illness caused by tiny parasites that are spread through mosquito bites and can lead to fever, chills, and flu‑like symptoms. The study drug MK-7602 is given as a hard capsule taken by mouth, and a matching placebo capsule that contains no active medicine is also used for comparison.

The main goal of the trial is to see whether multiple daily doses of the medication are safe and well tolerated in healthy volunteers and to gather early information on its pharmacokinetics, which means how the body absorbs, distributes, and removes the drug. Researchers will watch for any adverse event (side effect) and will measure the amount of drug in the blood, referred to as plasma, at several time points to understand how long the drug stays in the system, its half‑life, and how quickly it is cleared.

Participants will take the assigned capsule once each day for seven days. During this period, short clinic visits will be scheduled to collect blood samples and check for any side effects. After the final dose, additional blood draws will be done to complete the safety checks and the drug‑level measurements, after which participants will be monitored for a short follow‑up period.

The research process

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

Step 1
Receive study medication
After joining the study you will be given either the active drug mk-7602 or a matching placebo. both are provided as hard capsules that are taken by mouth.
The active drug contains 400 mg of the investigational substance, while the placebo contains no active ingredient.
Step 2
Take first dose
On the first day you will swallow one capsule with a glass of water, preferably in the morning, and you will not eat or drink anything that could interfere with the medication for at least 30 minutes before and after taking it.
Step 3
Continue daily dosing
For the next six days you will repeat the same procedure: one capsule taken orally each day, at roughly the same time each morning, for a total of 7 days of dosing.
Each dose is identical in strength (400 mg) and form (hard capsule).
Step 4
Final dose and study completion
On day seven you will take the last capsule in the same manner as the previous doses.
After the final dose the study medication period ends and you will no longer need to take any study tablets.

Who can join the trial?

4 criteria

Be in good health – you should not have any serious illnesses or medical problems.
Be a male or female – the study includes participants of any gender.
Be a healthy volunteer – you must be willing to take part and not have conditions that could affect the study.
Be within the age range set by the study – only people who fall into the specific age group defined for the trial can join.

Who cannot join the trial?

4 criteria

History of serious problems with any of the following body systems: endocrine (hormone‑producing glands), gastrointestinal (GI) (stomach and intestines), cardiovascular (heart and blood vessels), hematological (blood), hepatic (liver), immunological (immune system), renal (kidneys), respiratory (lungs), genitourinary (urinary and reproductive organs), or major brain or nerve problems such as stroke or ongoing seizures.
Any past diagnosis of cancer (also called malignancy), which means a disease where abnormal cells grow uncontrollably.
Positive test results for any of the following infections: hepatitis B surface antigen (a marker of hepatitis B virus infection), hepatitis C antibodies (indicates exposure to hepatitis C virus), or human immunodeficiency virus (HIV) (the virus that can lead to AIDS).
Had a major operation or donated/lose about 1 unit of blood (roughly 500 mL) within the 4 weeks before the screening visit.

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Universitair Ziekenhuis Gent
Responsive
Gent, Belgium

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Investigated drugs

MK-7602 is an experimental oral medication being tested in a study with healthy volunteers. Participants take a hard capsule of this drug once a day for a week. The trial is looking at how safe the medication is, whether people can tolerate it without serious side effects, and how the drug moves through the body (its pharmacokinetics). By giving several doses over seven days, researchers can gather early information about the drug’s behavior in the bloodstream and decide if it can be studied further for treating disease.

What is already known about the treatment

MK-7602 - MK-7602 is taken as a hard gelatin capsule taken by mouth, typically 400 mg once daily. It is an experimental antimalarial drug that is currently in early clinical trials and has not yet been approved for general medical use. The medication is being studied to treat malaria by blocking a protein the parasite needs to grow, which stops the infection from spreading. It belongs to the class of antimalarial agents that act on the parasite’s metabolic pathways.

Investigated diseases

Malaria - Malaria is an infectious disease caused by Plasmodium parasites that are transmitted to humans through the bite of infected Anopheles mosquitoes. After entering the bloodstream, the parasites travel to the liver where they multiply and then re‑enter the blood to infect red blood cells. The infection of red blood cells leads to cycles of fever, chills, and sweating as the parasites rupture the cells. Over time, repeated cycles can cause anemia and enlargement of the spleen. If the parasite load increases, symptoms may become more frequent and last longer. The disease can persist for weeks to months if not cleared.