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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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 antibodies, or human immunodeficiency virus (HIV) - Has a history of gastrointestinal (GI) disease which might affect food and drug absorption, or has had gastric bypass or similar surgery

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Panel A MK-1403 + additive coformulation dose 1 		Participants will receive MK-1403 + additive coformulation dose 1 orally once daily.
  • Drug: MK-1403 + additive coformulation
    MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo Comparator
Panel A Placebo + additive coformulation dose 1 		Participants will receive Placebo + additive coformulation dose 1 orally once daily.
  • Drug: Placebo + additive coformulation
    Placebo + additive coformulation is a co-formulated product of placebo administered orally.
Experimental
Panel B MK-1403 + additive coformulation dose 2 		Participants will receive MK-1403 + additive coformulation dose 2 orally once daily
  • Drug: MK-1403 + additive coformulation
    MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally.
Placebo Comparator
Panel B Placebo + additive coformulation dose 2 		Participants will receive Placebo + additive coformulation dose 2 orally once daily
  • Drug: Placebo + additive coformulation
    Placebo + additive coformulation is a co-formulated product of placebo administered orally.

Recruiting Locations

ProSciento Inc. ( Site 0001)
Chula Vista, California 91911
Contact:
Study Coordinator
619-427-1300

Advanced Pharma CR, LLC ( Site 0003)
Miami, Florida 33147
Contact:
Study Coordinator
305-220-2727

QPS-MRA, LLC ( Site 0004)
South Miami, Florida 33143
Contact:
Study Coordinator
305-722-0970

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.