Recent Updates
Recently added Catalysts

MK1809

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01033318A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)PHASE1 COMPLETED 30Sep 11, 2007Jun 19, 2008Sep 26, 2018 -
Unlock Drug Trial Details
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
Unlock Study Endpoints
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
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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...

Unlock Eligibility Criteria