In short
MK-7602 is a chemically synthesised, investigational substance being studied for malaria. It is taken by mouth as a hard capsule and has no marketing authorisation in the product records. One completed Phase 1 trial in 40 healthy participants has evaluated its safety and how the body processes it.
Key points
- MK-7602 is an investigational substance with no marketing authorisation, supplied by Merck & Co. Inc.
- It is being studied for malaria, a parasitic disease.
- The only registered trial is a Phase 1 multiple ascending dose study in 40 healthy participants.
- The trial has completed and measured safety, tolerability and pharmacokinetics.
- MK-7602 is given as a hard capsule for oral use.
- Primary outcomes include adverse events and plasma levels of the drug over time.
What is MK-7602?
MK-7602 is a chemically synthesised substance that is being investigated for the treatment of malaria. In the EU Clinical Trials Information System (CTIS) product records it is classified under parasitic diseases, which places it in the area of medicines aimed at infections caused by parasites. The substance is described as an investigational medicine: there is no marketing authorisation in the product records, and the supplier named in the registry is Merck & Co. Inc. The UK Medicines and Healthcare products Regulatory Agency (MHRA) products website does not list a product-specific page for MK-7602, which is consistent with its status as a substance still in early clinical development.
How does MK-7602 work?
The registered trial documents do not describe the molecular target or mechanism of action of MK-7602, and the supplementary source provided is a general MHRA search page that does not give product information for this substance. Because no source in the data states how MK-7602 acts against the malaria parasite, the mechanism of action is not described here. The registered Phase 1 study focuses on safety, tolerability and pharmacokinetics rather than on how the substance kills or inhibits the parasite.
Which conditions is it studied for?
The registry record lists one condition for the trial of MK-7602:
- Malaria — a parasitic disease caused by Plasmodium parasites, transmitted by mosquito bites. The registered trial is a Phase 1 study in healthy participants, so it does not yet test whether MK-7602 can treat people who have malaria; it first establishes how the body handles the substance and whether it is tolerated.
How is MK-7602 given?
According to the CTIS product records, MK-7602 is prepared as a hard capsule and is given by oral use, meaning it is swallowed. In the registered trial the intervention is described as MK-7602 400 mg taken orally, with a placebo arm made of microcrystalline cellulose, lactose monohydrate and magnesium stearate (non-bovine). The study uses a multiple ascending dose design, which means participants receive repeated doses over a period of seven days, with the dose level increased between different groups of participants.
What do the clinical trials show?
There is one registered clinical trial of MK-7602 in the data provided: a Phase 1 multiple ascending dose study in healthy participants, with the EU CT number 2023-503738-36-00. The trial has the status Completed and enrolled 40 participants. It is an interventional study, meaning participants received the investigational substance or placebo according to a defined plan.
The primary outcomes of the trial cover two areas. The first is safety and tolerability: the number of participants who experience at least one adverse event, and the number who discontinue study treatment because of an adverse event. The second is pharmacokinetics, which describes how the body absorbs, distributes, metabolises and removes a drug. The trial measures the area under the curve from time 0 to the end of the dosing interval (AUC0-tau), which reflects total drug exposure over a dosing interval; the maximum plasma concentration (Cmax); the trough plasma concentration (Ctrough); the time to reach maximum plasma concentration (Tmax); the apparent plasma terminal half-life (t1/2); the apparent total clearance from plasma after oral administration (CL/F); the apparent volume of distribution during the terminal phase (Vz/F); and the accumulation ratios for AUC0-tau and Cmax. These measurements help researchers understand how often and at what dose the substance might be given in future studies.
The trial enrolled healthy participants rather than people with malaria, which is typical for a first-in-human or early Phase 1 study. The brief summary states that the objectives were to evaluate the safety and tolerability of multiple doses of MK-7602 over seven days and to obtain preliminary plasma pharmacokinetic data following multiple dose regimens over seven days.
What side effects are known?
The supplementary source provided is a general MHRA search page and does not contain side effect information for MK-7602. The registered trial lists adverse events among its primary outcomes, but the data provided does not report the results of those measurements. Therefore no specific side effects of MK-7602 can be listed from the available sources.