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Completed

NCT Number: NCT01033318

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK1809

Drug

single oral doses of MK1809

Comparator: losartan

Drug

single oral doses of 100 mg Losartan

Other names: Losartan

Comparator: placebo

Drug

Placebo to MK1809

Primary outcomes

  1. 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

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

    Time frame: 24 hours postdose

  3. 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

  1. 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

  2. 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

  3. 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

  4. Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite

    Time frame: Through 32 hours postdose

  5. Part 2: Trough plasma concentration of the E3174 metabolite

    Time frame: Through 32 hours postdose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 16, 2009
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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