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MK1809

Phase 1

Hypertension | Small molecule | Cardiovascular |Merck & Company, Inc.|Last Updated: Sep 26, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

MK1809 · 1 trial · 1 indication

Phase 1 1
NCT01033318A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)Hypertension
COMPLETED30 Analytics
PHASE1COMPLETED
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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)
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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 A-1EXPERIMENTALPart 1; Panel A; Sequence 1: 2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan
Part 1 A-2EXPERIMENTALPart 1; Panel A; Sequence 2: Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809
Part 1 A-3EXPERIMENTALPart 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809
Part 1 A-4EXPERIMENTALPart 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo
Part 1 A-5EXPERIMENTALPart 1; Panel A; Sequence 5: Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809
Part 1 B-1EXPERIMENTALPart 1; Panel B; Sequence 1: 5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food
Part 1 B-2EXPERIMENTALPart 1; Panel B; Sequence 2: 5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food
Part 1 B-3EXPERIMENTALPart 1; Panel B; Sequence 3: 5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food
Part 1 B-4EXPERIMENTALPart 1; Panel B; Sequence 4: Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food
Part 1 B-5EXPERIMENTALPart 1; Panel B; Sequence 5: Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food
Part 2 C-1EXPERIMENTALPart 2; Panel C; Sequence 1: 50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan
Part 2 C-2EXPERIMENTALPart 2; Panel C; Sequence 2: 50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809
Part 2 C-3EXPERIMENTALPart 2; Panel C; Sequence 3: Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo
Part 2 C-4EXPERIMENTALPart 2; Panel C; Sequence 4: 50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809
Part 2 C-5EXPERIMENTALPart 2; Panel C; Sequence 5: Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809

Interventions

NameTypeDescription
MK1809DRUGsingle oral doses of MK1809
Comparator: LosartanDRUGsingle oral doses of 100 mg Losartan
Comparator: PlaceboDRUGPlacebo to MK1809
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: Part 1: * Nonsmoker for at least 6 months * Body Mass Index (BMI) less than or equal to 29 kg/m2 * In overall good health Part 2: * Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2 * In overall good health (patients with hypertension and/or hyperli...

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Frequently asked questions about MK1809

What is MK1809 used for?

MK1809 is an investigational small molecule being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes MK1809?

MK1809 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for hypertension.

What phase is MK1809 in?

MK1809 is in Phase 1 clinical development. It is an investigational drug for hypertension and has not been approved by the FDA or any other regulatory agency. The drug is still in the early stages of clinical testing.

What clinical trials is MK1809 in?

MK1809 has one completed Phase 1 clinical trial, registered as NCT01033318, which studied the pharmacokinetics and pharmacodynamics of the drug in 30 participants with hypertension. The trial was randomized, double-blind, and controlled, and included healthy volunteers.

Is MK1809 FDA approved?

No, MK1809 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for hypertension. The drug has completed one Phase 1 trial, but it remains in clinical development and has not received regulatory approval.