A Single Dose Study of MK3614

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

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.


Condition Intervention Phase
Hypertension
Drug: MK3614
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK3614

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - Sequence 1
.25 mg - 1.25 mg - Pbo - 20 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel A - Sequence 2
.25 mg - 1.25 mg - 5 mg - Pbo
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel A - Sequence 3
.25 mg - Pbo - 5 mg - 20 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel A - Sequence 4
Pbo - 1.25 mg - 5 mg - 20 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel B - Sequence 1
.5 mg - 2.5 mg - Pbo - 40 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel B - Sequence 2
.5 mg - 2.5 mg - 10 mg - Pbo
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel B - Sequence 3
.5 mg - Pbo - 10 mg - 40 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo
Experimental: Panel B - Sequence 4
Pbo - 2.5 mg - 10 mg - 40 mg
Drug: MK3614
single rising oral dose of MK3614
Drug: Comparator: Placebo
single dose oral placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104545

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01104545     History of Changes
Other Study ID Numbers: 2010_525, MK3614-001
Study First Received: April 13, 2010
Last Updated: April 13, 2010
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014