A Multiple Dose Study of MK-3614 (MK-3614-002)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-3614; Placebo for MK-3614
Intervention description: Participants were administered 0.25 mg tablet, orally for a total daily dose according to randomization.; Participants were administered dose matched placebo tablets according to randomization.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      multiple doses of MK-3614 in male participants with mild to moderate hypertension. The
      primary hypotheses are: 1) Multiple oral doses of MK-3614 are sufficiently safe and well
      tolerated to permit continued clinical investigation 2) Aortic Augmentation Index (Aix) is
      reduced 24 hours post the last dose of MK-3614 administered compared to placebo and 3)
      Increase in the 12-hour weighted averages (TWA 0-12hours) of the heart rate is within 15
      beats per minute (bpm) of baseline on first day of multiple dosing of MK-3614 and within 10
      bpm of baseline on last day of multiple dosing of MK-3614.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has mild to moderate hypertension

          -  Has grade 1 or 2 arterial hypertension being treated with a single antihypertensive
             drug

          -  Has been a nonsmoker and/or has not used nicotine or nicotine-containing products for
             at least approximately 6 months; or who have discontinued smoking or the use of
             nicotine/nicotine-containing products for at least approximately 3 months

          -  Is in generally good health

        Exclusion Criteria:

          -  Has a history of clinically significant abnormalities or diseases

          -  Has a history of stroke, chronic seizures, or major neurological disorder

          -  Has a functional disability that can interfere with rising from a sitting position to
             the standing position

          -  Has any personal or family history of a bleeding or a clotting disorder

          -  Has a history of frequent nose bleeds or has recurrent or active gingivitis

          -  Has a history of cancer

          -  Has a history of clinically significant cardiac disease

          -  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

          -  Consumes excessive amounts of alcohol

          -  Consumes excessive amounts of caffeinated beverages per day

          -  Has had major surgery, donated or lost 1 unit of blood or participated in another
             investigational study within 4 weeks of study

          -  Has a history of significant multiple and/or severe allergies (including latex) to
             prescription or non-prescription drugs or food

          -  Is currently a regular user of any illicit drugs or has a history of drug abuse within
             approximately 1 year