A Multiple Dose Study of MK3614 (3614-002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01033643
First received: December 15, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

This study will evaluate if MK3614, given in multiple rising doses, is safe and tolerated in male subjects with mild to moderate hypertension.


Condition Intervention Phase
Hypertension
Drug: MK3614
Drug: Comparator: MK3614 .75 mg 1st
Drug: Comparator: MK3614 titrating down dose
Drug: Comparator: MK3614 multiple rising dose
Drug: Comparator: Placebo Panel A
Drug: Comparator: Placebo Panel B-C
Drug: Comparator: Placebo Panel D
Drug: Comparator: Placebo Panel E
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple 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 multiple rising oral doses of MK3614, measured by the 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: May 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A
0.25 mg MK3614 or Placebo
Drug: MK3614
0.25 mg BID every 12 hours for 10 days
Drug: Comparator: Placebo Panel A
Oral Placebo BID every 12 hours for 10 days
Experimental: Panel B
0.50 mg and 0.25 mg MK3614 or Placebo
Drug: Comparator: MK3614 .75 mg 1st
0.50 mg in the AM, 0.25 mg in the PM 12 hours apart for 10 days
Drug: Comparator: Placebo Panel B-C
Oral Placebo in the AM, 0.25 mg in the PM 12 hours apart for 10 days
Experimental: Panel C
0.50 mg and 0.25 mg MK3614 or Placebo
Drug: Comparator: MK3614 .75 mg 1st
0.50 mg in the AM, 0.25 mg in the PM 12 hours apart for 10 days
Drug: Comparator: Placebo Panel B-C
Oral Placebo in the AM, 0.25 mg in the PM 12 hours apart for 10 days
Experimental: Panel D
0.50 mg MK3614 or Placebo
Drug: Comparator: MK3614 titrating down dose
Day 1 subjects will receive 0.50 mg three times a day every 8 hours. Days 4-13 subjects will receive 0.50 mg twice a day every 12 hours.
Drug: Comparator: Placebo Panel D
Day 1 subjects will receive oral placebo three times a day every 8 hours. Days 4-13 subjects will receive oral placebo twice a day every 12 hours.
Experimental: Panel E
0.50 mg, 0.25 mg and 0.75 mg MK3614 or Placebo
Drug: Comparator: MK3614 multiple rising dose
Day 1 subjects will receive 0.50 mg twice a day every 12 hours. Day 2 subjects will receive 3 doses (0.50/0.50/0.25 mg) each 8 hours apart. Days 3-4 subjects will receive 3 doses of 0.50 mgs 8 hours apart. Days 5-14 subjects will receive 0.75 mgs twice a day every 12 hours.
Drug: Comparator: Placebo Panel E
Day 1 subjects will receive oral placebo twice a day every 12 hours. Day 2 subjects will receive 3 doses of oral placebo each 8 hours apart. Days 3-4 subjects will receive 3 doses of oral placebo 8 hours apart. Days 5-14 subjects will receive oral placebo twice a day every 12 hours.

  Eligibility

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

Inclusion Criteria:

  • hypertensive male subjects
  • an otherwise healthy subject with grade 1 or 2 arterial hypertension being treated with a single antihypertensive drug
  • subject is a nonsmoker and has not used nicotine or nicotine products for at least 6 months
  • subject is in generally good health

Exclusion Criteria:

  • subject has a history of clinically significant abnormalities or diseases
  • subject has a history of stroke, chronic seizures, or major neurological disorder
  • subject has a functional disability that can interfere with rising from a sitting position to the standing position
  • subject has any personal or family history of a bleeding or a clotting disorder
  • subject has a history of frequent nose bleeds or has recurrent or active gingivitis
  • subject has a history of cancer
  • subject has a history of clinically significant cardiac disease
  • subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies approximately 2 weeks prior to the administration of study drug
  • subject consumes excessive amounts of alcohol
  • subject consumes excessive amounts of caffeinated beverages per day
  • subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of study
  • subject has a history of significant multiple and/or severe allergies (including latex) to prescription or non-prescription drugs or food
  • subject is currently a regular user of any illicit drugs or has a history of drug abuse within approximately 1 year
  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: NCT01033643

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01033643     History of Changes
Other Study ID Numbers: 3614-002, MK3614-002, 2009_704
Study First Received: December 15, 2009
Last Updated: July 3, 2014
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 September 18, 2014