A Study of the Pharmacokinetics and Pharmacodynamics of MK1809

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01033318
First received: December 15, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 15, 2009
December 15, 2009
April 2008
June 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state [ Time Frame: 24 hours postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite [ Time Frame: Through 32 hours postdose ] [ Designated as safety issue: Yes ]
  • Part 2: Trough plasma concentration of the E3174 metabolite [ Time Frame: Through 32 hours postdose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study of the Pharmacokinetics and Pharmacodynamics of MK1809
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK1809
    single oral doses of MK1809
    Other Name: MK1809
  • Drug: Comparator: Losartan
    single oral doses of 100 mg Losartan
    Other Name: Losartan
  • Drug: Comparator: Placebo
    Placebo to MK1809
  • Experimental: Part 1 A-1

    Part 1; Panel A; Sequence 1:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 A-2

    Part 1; Panel A; Sequence 2:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 A-3
    Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809
    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 A-4
    Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo
    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 A-5

    Part 1; Panel A; Sequence 5:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 B-1

    Part 1; Panel B; Sequence 1:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Placebo
  • Experimental: Part 1 B-2

    Part 1; Panel B; Sequence 2:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 B-3

    Part 1; Panel B; Sequence 3:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
  • Experimental: Part 1 B-4

    Part 1; Panel B; Sequence 4:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 1 B-5

    Part 1; Panel B; Sequence 5:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 2 C-1

    Part 2; Panel C; Sequence 1:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 2 C-2

    Part 2; Panel C; Sequence 2:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 2 C-3

    Part 2; Panel C; Sequence 3:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 2 C-4

    Part 2; Panel C; Sequence 4:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
  • Experimental: Part 2 C-5

    Part 2; Panel C; Sequence 5:

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

    Interventions:
    • Drug: MK1809
    • Drug: Comparator: Losartan
    • Drug: Comparator: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01033318
2009_703, MK1809-001
No
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP