A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)
ConditionHealthy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMerck Sharp & Dohme LLC
About this trial
The purpose of this trial is to learn about a trial medicine called MK-1403. Researchers designed MK-1403 to treat a type of heart and blood vessel disease called atherosclerotic cardiovascular disease (ASCVD).
Before giving a trial medicine to people with a health condition, researchers first do clinical trials in healthy people. This trial will help researchers learn about the safety of MK-1403 and if participants tolerate it. Tolerate means participants receive the trial medicine and they do not need to stop taking it due to health problems. The trial will also measure what happens to MK 1403 in a healthy person's body over time.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health
Has a body mass index (BMI) ≥ 18 and ≤ 32 kg/m²
Disqualifiers
Has history of cancer (malignancy)
Has a history of significant multiple and/or severe allergies
Trial design
Design model
Crossover
Treatments tested in this trial
MK-1403 formulation (FM) 1 + additive
DrugOral tablet
MK-1403 FM2 + additive
DrugOral tablet
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: MK-1403 formulation (FM) 1 + additive, FedExperimental treatment 1 intervention
Group B: MK-1403 FM1 + additive, FastedExperimental treatment 1 intervention
Group C: MK-1403 FM2 + additive, FedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame
Up to approximately 4 weeks2
Number of Participants Who Discontinue the Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Time frame
Up to approximately 2 weeks3
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
Blood samples will be collected to determine the AUC0-inf of MK-1403 in plasma.
Time frame
Predose and at designated timepoints (up to 72 hours postdose)4
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of MK-1403
Blood samples will be collected to determine the AUC0-last of MK-1403 in plasma.
Time frame
Predose and at designated timepoints (up to 72 hours postdose)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: