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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-11

Study Completion Date

2008-06-19

Brief Summary

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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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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1 A-1

Part 1; Panel A; Sequence 1:

2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 A-2

Part 1; Panel A; Sequence 2:

Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 A-3

Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 A-4

Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 A-5

Part 1; Panel A; Sequence 5:

Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 B-1

Part 1; Panel B; Sequence 1:

5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 B-2

Part 1; Panel B; Sequence 2:

5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 B-3

Part 1; Panel B; Sequence 3:

5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Part 1 B-4

Part 1; Panel B; Sequence 4:

Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 1 B-5

Part 1; Panel B; Sequence 5:

Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 2 C-1

Part 2; Panel C; Sequence 1:

50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 2 C-2

Part 2; Panel C; Sequence 2:

50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 2 C-3

Part 2; Panel C; Sequence 3:

Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 2 C-4

Part 2; Panel C; Sequence 4:

50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Part 2 C-5

Part 2; Panel C; Sequence 5:

Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809

Group Type EXPERIMENTAL

MK1809

Intervention Type DRUG

single oral doses of MK1809

Comparator: Losartan

Intervention Type DRUG

single oral doses of 100 mg Losartan

Comparator: Placebo

Intervention Type DRUG

Placebo to MK1809

Interventions

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MK1809

single oral doses of MK1809

Intervention Type DRUG

Comparator: Losartan

single oral doses of 100 mg Losartan

Intervention Type DRUG

Comparator: Placebo

Placebo to MK1809

Intervention Type DRUG

Other Intervention Names

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Losartan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes