A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-1403 in Participants With Type 2 Diabetes Mellitus
Merck Sharp & Dohme LLC
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Has a confirmed diagnosis of Type 2 diabetes mellitus (T2DM) * Has body mass index (BMI) between 18 and 40 kg/m\^2, inclusive Exclusion Criteria: * Has Type 1 diabetes mellitus or secondary types of diabetes * Has a history of congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4) * Has history of myocardial infarction, uncontrolled arrhythmias, cardiac revascularization, angina, unstable peripheral arterial disease and/or stroke * Has history of cancer (malignancy) * Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibod…
Interventions
- DrugMK-1403 + additive coformulation
MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
- DrugPlacebo + additive coformulation
Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Locations (4)
- ProSciento Inc. ( Site 0001)Chula Vista, California
- QPS-MRA, LLC ( Site 0004)Miami, Florida
- Advanced Pharma CR, LLC ( Site 0003)Miami, Florida
- Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005)Springfield, Missouri