A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)

Merck Sharp & Dohme LLC30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

MK1809DRUG

single oral doses of MK1809

Comparator: LosartanDRUG

single oral doses of 100 mg Losartan

Comparator: PlaceboDRUG

Placebo to MK1809

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state

Time frame: Through 32 hours postdose

Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state

Time frame: 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

Time frame: Duration of study and up to 14 days after administration of the last dose of study drug

Secondary Outcomes

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)

Time frame: 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)

Time frame: Through 32 hours postdose

Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability

Time frame: 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

Time frame: Through 32 hours postdose

Part 2: Trough plasma concentration of the E3174 metabolite

Data from ClinicalTrials.gov

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