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

Merck Sharp & Dohme (MSD) logo

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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