Hypertension
Conditions
Keywords
Hypertension
Brief summary
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.
Interventions
DRUGMK1809
single oral doses of MK1809
single oral doses of 100 mg Losartan
DRUGComparator: Placebo
Placebo to MK1809
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 hyperlipidemia are accepted)
Exclusion criteria
Part 1: * History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years * History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder * History of cancer * Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines) * Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety) * History of asthma, severe wheezing, COPD, or other pulmonary disease * Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties * Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days * Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years) * Nitrate therapy within 4 weeks * History of significant drug allergy or history of food allergies Part 2 * History of any clinically significant cardiac or cardiovascular disease (other than hypertension) * History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder * History of cancer * History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines) * Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety) * History of asthma, severe wheezing, COPD, or other pulmonary disease * Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties * Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years) * Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days * Nitrate therapy within 4 weeks * History of significant drug allergy
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite | Through 32 hours postdose |
| 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 2: Trough plasma concentration of the E3174 metabolite | Through 32 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 |
Outcome results
None listed