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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A MK-1403 + additive coformulation dose 1 | Experimental | Participants will receive MK-1403 + additive coformulation dose 1 orally once daily. |
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| Panel A Placebo + additive coformulation dose 1 | Placebo Comparator | Participants will receive Placebo + additive coformulation dose 1 orally once daily. |
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| Panel B MK-1403 + additive coformulation dose 2 | Experimental | Participants will receive MK-1403 + additive coformulation dose 2 orally once daily |
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| Panel B Placebo + additive coformulation dose 2 | Placebo Comparator | Participants will receive Placebo + additive coformulation dose 2 orally once daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1403 + additive coformulation | Drug | MK-1403 + additive coformulation is a co-formulated product of MK-1403 administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Up to approximately 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 24-hours postdose on Day 14 |
| Plasma concentration of MK-1403 at 24 Hours Postdose (C24) on Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento Inc. ( Site 0001) | Recruiting | Chula Vista | California | 91911 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo + additive coformulation | Drug | Placebo + additive coformulation is a co-formulated product of placebo administered orally. |
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Blood samples will be collected to determine the C24 of MK-1403 in plasma on Day 14. |
| 24-hour postdose on Day 14 |
| Advanced Pharma CR, LLC ( Site 0003) | Recruiting | Miami | Florida | 33147 | United States |
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| QPS-MRA, LLC ( Site 0004) | Recruiting | South Miami | Florida | 33143 | United States |
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| Bio-Kinetic Clinical Applications, LLC dba QPS-MO ( Site 0005) | Active, not recruiting | Springfield | Missouri | 65802 | United States |
| D004700 | Endocrine System Diseases |