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

NCT01033318 | Completed Phase 1

• 3 other identifiers: 1809-001MK1809-0012009_703
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (3)

• Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state

  Through 32 hours postdose

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

  24 hours postdose

• 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

  Duration of study and up to 14 days after administration of the last dose of study drug

Secondary Outcomes (5)

• 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)

  24 hours postdose

• 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)

  Through 32 hours postdose

• Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability

  Duration of study and up to 14 days after administration of the last dose of study drug

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

  Through 32 hours postdose

• Part 2: Trough plasma concentration of the E3174 metabolite

  Through 32 hours postdose

Study Arms (15)

Part 1 A-1

EXPERIMENTAL

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

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

Part 1 A-2

EXPERIMENTAL

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

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

Part 1 A-3

EXPERIMENTAL

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

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

Part 1 A-4

EXPERIMENTAL

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

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

Part 1 A-5

EXPERIMENTAL

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

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

Part 1 B-1

EXPERIMENTAL

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

Drug: MK1809; Drug: Comparator: Placebo

Part 1 B-2

EXPERIMENTAL

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

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

Part 1 B-3

EXPERIMENTAL

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

Drug: MK1809; Drug: Comparator: Losartan

Part 1 B-4

EXPERIMENTAL

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

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

Part 1 B-5

EXPERIMENTAL

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

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

Part 2 C-1

EXPERIMENTAL

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

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

Part 2 C-2

EXPERIMENTAL

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

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

Part 2 C-3

EXPERIMENTAL

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

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

Part 2 C-4

EXPERIMENTAL

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

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

Part 2 C-5

EXPERIMENTAL

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

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

Interventions

MK1809 DRUG

single oral doses of MK1809

Part 1 A-1; Part 1 A-2; Part 1 A-3; Part 1 A-4; Part 1 A-5; Part 1 B-1; Part 1 B-2; Part 1 B-3; Part 1 B-4; Part 1 B-5; Part 2 C-1; Part 2 C-2; Part 2 C-3; Part 2 C-4; Part 2 C-5

Comparator: Losartan DRUG

single oral doses of 100 mg Losartan

Also known as: Losartan

Part 1 A-1; Part 1 A-2; Part 1 A-3; Part 1 A-4; Part 1 A-5; Part 1 B-2; Part 1 B-3; Part 1 B-4; Part 1 B-5; Part 2 C-1; Part 2 C-2; Part 2 C-3; Part 2 C-4; Part 2 C-5

Comparator: Placebo DRUG

Placebo to MK1809

Part 1 A-1; Part 1 A-2; Part 1 A-3; Part 1 A-4; Part 1 A-5; Part 1 B-1; Part 1 B-2; Part 1 B-4; Part 1 B-5; Part 2 C-1; Part 2 C-2; Part 2 C-3; Part 2 C-4; Part 2 C-5

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: September 11, 2007
• Primary Completion: June 19, 2008
• Study Completion: June 19, 2008
• Last Updated: September 26, 2018

Record last verified: 2018-09