In short
MK-1403 is an investigational chemical substance developed by Merck & Co. Inc. that is being studied for atherosclerosis, a cardiovascular condition. It is given orally as a hard capsule in two formulations, MK-1403 F1 and MK-1403 F2. The two completed Phase 1 trials enrolled 24 and 16 healthy men to evaluate safety and tolerability of single oral doses.
Key points
- MK-1403 is an investigational chemical substance with no marketing authorisation.
- It is being studied for atherosclerosis, a cardiovascular disease.
- Both registered trials are Phase 1 and have been completed.
- The trials enrolled 24 and 16 healthy male participants.
- MK-1403 is given as a hard capsule taken orally in two formulations.
- The primary outcome in both trials is the number of participants with adverse events.
What is MK-1403?
MK-1403 is a chemically synthesised substance classified in the cardiovascular therapeutic area (ATC group C14). It is an investigational drug with no marketing authorisation in the product records, meaning it is not yet approved as a medicine. The substance is supplied by Merck & Co. Inc. and appears in the registry under the product names MK-1403 F1 and MK-1403 F2, which refer to two different formulations of the same active substance.
How does MK-1403 work?
The registry data do not describe the mechanism of action of MK-1403. The substance is being studied in the cardiovascular disease area, specifically for atherosclerosis, a condition in which fatty deposits build up inside arteries. The exact molecular target or mode of action is not stated in the available trial records.
Which conditions is MK-1403 studied for?
- Atherosclerosis — a cardiovascular condition in which plaque builds up inside the arteries, narrowing them and reducing blood flow. Both registered trials of MK-1403 list this as the condition studied.
How is MK-1403 given?
MK-1403 is given by mouth as a hard capsule. Two formulations are listed in the product records: MK-1403 F1 and MK-1403 F2. In the first trial, single oral doses of 300 mg were tested for both formulations, with some participants also receiving capsules containing microcrystalline cellulose and sodium caprate as an additive. In the second trial, single oral doses of 240 mg were tested, and one arm included famotidine, a medicine that reduces stomach acid.
What do the clinical trials show?
Two Phase 1 trials of MK-1403 are registered, both completed and both conducted in healthy men. The first trial enrolled 24 participants and evaluated the safety and tolerability of single oral doses of MK-1403 administered with an additive. The second trial enrolled 16 participants and was a single-dose formulation pharmacokinetic (PK) study, meaning it measured how the drug is absorbed, distributed and eliminated by the body.
What are the trials measuring?
In both trials, the primary outcome measures are the number of participants who experience at least one adverse event (AE) and the number who discontinue study treatment due to an AE. An adverse event is any unwanted medical occurrence during the study, whether or not it is considered related to the drug. The second trial also included pharmacokinetic measurements to compare the two formulations.
Who can take part in these trials?
Both trials enrolled healthy men. The first trial included 24 participants, and the second included 16 participants. The trials are completed, so no new participants are being recruited. Further details on eligibility criteria are available in the registry records.
What side effects are known?
The trial records list adverse events as the primary outcome, but the actual side effects observed in these completed trials are not reported in the registry data provided. No supplementary sources describing known side effects of MK-1403 are available.