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| ID | Type | Description | Link |
|---|---|---|---|
| MK1809-001 | |||
| 2009_703 |
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The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 A-1 | Experimental | Part 1; Panel A; Sequence 1: 2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan |
|
| Part 1 A-2 | Experimental | Part 1; Panel A; Sequence 2: Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809 |
|
| Part 1 A-3 | Experimental | Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809 |
|
| Part 1 A-4 | Experimental | Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo |
|
| Part 1 A-5 | Experimental | Part 1; Panel A; Sequence 5: Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK1809 | Drug | single oral doses of MK1809 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state | Through 32 hours postdose | |
| Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state | 24 hours postdose | |
| Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences | Duration of study and up to 14 days after administration of the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state) | 24 hours postdose | |
| Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state) |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
Part 2
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Part 1 B-1 | Experimental | Part 1; Panel B; Sequence 1: 5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food |
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| Part 1 B-2 | Experimental | Part 1; Panel B; Sequence 2: 5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food |
|
| Part 1 B-3 | Experimental | Part 1; Panel B; Sequence 3: 5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food |
|
| Part 1 B-4 | Experimental | Part 1; Panel B; Sequence 4: Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food |
|
| Part 1 B-5 | Experimental | Part 1; Panel B; Sequence 5: Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food |
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| Part 2 C-1 | Experimental | Part 2; Panel C; Sequence 1: 50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan |
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| Part 2 C-2 | Experimental | Part 2; Panel C; Sequence 2: 50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809 |
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| Part 2 C-3 | Experimental | Part 2; Panel C; Sequence 3: Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo |
|
| Part 2 C-4 | Experimental | Part 2; Panel C; Sequence 4: 50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809 |
|
| Part 2 C-5 | Experimental | Part 2; Panel C; Sequence 5: Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809 |
|
| Comparator: Losartan | Drug | single oral doses of 100 mg Losartan |
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| Comparator: Placebo | Drug | Placebo to MK1809 |
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| Through 32 hours postdose |
| Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability | Duration of study and up to 14 days after administration of the last dose of study drug |
| Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite | Through 32 hours postdose |
| Part 2: Trough plasma concentration of the E3174 metabolite | Through 32 hours postdose |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |