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A Single Dose Study of MK3614

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01104545
First received: April 13, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted

April 13, 2010
April 13, 2010
November 2008
May 2009   (final data collection date for primary outcome measure)
safety and tolerability of MK3614 given as single doses measured by number of clinical and laboratory adverse experiences [ Time Frame: 14 days after administration of last dose of study drug ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
A Single Dose Study of MK3614
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK3614

This study will determine if MK3614, given as single doses, is safe and well tolerated in healthy males and male subjects with mild to moderate hypertension.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK3614
    single rising oral dose of MK3614
  • Drug: Comparator: Placebo
    single dose oral placebo
  • Experimental: Panel A - Sequence 1
    .25 mg - 1.25 mg - Pbo - 20 mg
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel A - Sequence 2
    .25 mg - 1.25 mg - 5 mg - Pbo
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel A - Sequence 3
    .25 mg - Pbo - 5 mg - 20 mg
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel A - Sequence 4
    Pbo - 1.25 mg - 5 mg - 20 mg
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel B - Sequence 1
    .5 mg - 2.5 mg - Pbo - 40 mg
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel B - Sequence 2
    .5 mg - 2.5 mg - 10 mg - Pbo
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel B - Sequence 3
    .5 mg - Pbo - 10 mg - 40 mg
    Interventions:
    • Drug: MK3614
    • Drug: Comparator: Placebo
  • Experimental: Panel B - Sequence 4
    Pbo - 2.5 mg - 10 mg - 40 mg
    Interventions:
    • Drug: MK3614
    • 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
24
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects between 18 to 45 years of age; otherwise healthy subjects between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
  • Subject is in good general health
  • Subject is a nonsmoker

Exclusion Criteria:

  • Subject has a history of stroke, seizure or major neurological disease
  • Subject has functional disability that can interfere with rising from a sitting position to a standing position
  • Subject has a family history of a bleeding or clotting disorder
  • Subject has a history of cancer
  • Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
  • Subject consumes excessive amounts of alcohol or caffeine Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01104545
2010_525, MK3614-001
No
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

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