A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006)

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

  • Diabetes Mellitus, Type 2

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