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A Multiple Dose Study of MK3614 (3614-002)

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ClinicalTrials.gov Identifier: NCT01033643
Recruitment Status : Completed
First Posted : December 16, 2009
Last Update Posted : June 24, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3614
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033643


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01033643     History of Changes
Other Study ID Numbers: 3614-002
MK3614-002
2009_704
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015