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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hypertension

Treatments: Drug: Comparator: Placebo; Drug: MK1809; Drug: Comparator: Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033318

2009_703

1809-001

MK1809-001

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 15 patient groups

Part 1 A-1

Experimental group

Description:

Part 1; Panel A; Sequence 1: 2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 A-2

Experimental group

Description:

Part 1; Panel A; Sequence 2: Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 A-3

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 A-4

Experimental group

Description:

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

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 A-5

Experimental group

Description:

Part 1; Panel A; Sequence 5: Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 B-1

Experimental group

Description:

Part 1; Panel B; Sequence 1: 5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food

Treatment:

Drug: Comparator: Placebo

Drug: MK1809

Part 1 B-2

Experimental group

Description:

Part 1; Panel B; Sequence 2: 5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 B-3

Experimental group

Description:

Part 1; Panel B; Sequence 3: 5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food

Treatment:

Drug: Comparator: Losartan

Drug: MK1809

Part 1 B-4

Experimental group

Description:

Part 1; Panel B; Sequence 4: Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 1 B-5

Experimental group

Description:

Part 1; Panel B; Sequence 5: Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 2 C-1

Experimental group

Description:

Part 2; Panel C; Sequence 1: 50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 2 C-2

Experimental group

Description:

Part 2; Panel C; Sequence 2: 50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 2 C-3

Experimental group

Description:

Part 2; Panel C; Sequence 3: Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 2 C-4

Experimental group

Description:

Part 2; Panel C; Sequence 4: 50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809

Part 2 C-5

Experimental group

Description:

Part 2; Panel C; Sequence 5: Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809

Treatment:

Drug: Comparator: Placebo

Drug: Comparator: Losartan

Drug: MK1809