The purpose of this study is to learn about the safety and if people tolerate a study medicine called MK-1403. The study will also measure what happens to MK-1403 in the body of a person with type 2 diabetes (T2D) over time (pharmacokinetic or PK study), and how it affects the amount of high-sensitivity C-reactive protein (hsCRP) in a person's blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
53
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Anaheim Clinical Trials ( Site 0006)
Anaheim, California, United States
ProSciento Inc. ( Site 0001)
Chula Vista, California, United States
Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida, United States
QPS-MRA, LLC ( Site 0004)
South Miami, Florida, United States
Number of participants who experience one or more adverse events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.
Time frame: Up to approximately 28 days
Number of participants who discontinue study intervention due to adverse events
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Time frame: Up to approximately 14 days
Change from Baseline in Placebo-Corrected High Sensitivity C-Reactive Protein (hsCRP) Serum Concentration
Blood samples will be collected to determine the change from baseline in placebo-corrected hsCRP.
Time frame: Baseline and 24-hours postdose on Day 14
Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14
Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14.
Time frame: 24-hour postdose on Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)
Springfield, Missouri, United States