Clinical trial NCT01033318: A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)
Official title: A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
timeFrame: Through 32 hours postdose
measure: Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state
timeFrame: 24 hours postdose
measure: 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
timeFrame: Duration of study and up to 14 days after administration of the last dose of study drug
Secondary outcomes:
measure: 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)
timeFrame: 24 hours postdose
measure: 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)
timeFrame: Through 32 hours postdose
measure: Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability
timeFrame: Duration of study and up to 14 days after administration of the last dose of study drug
measure: Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite
timeFrame: Through 32 hours postdose
measure: Part 2: Trough plasma concentration of the E3174 metabolite
timeFrame: Through 32 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: