A Single Dose Study of MK3614 - Full Text View

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:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

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 June 18, 2013