A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-8457; Placebo for MK-8457
Intervention description: 10 x 10-mg capsule BID for 10 days; 10 x 10-mg capsule BID for 10 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic
      blood pressure in participants with mild to moderate hypertension in addition to safety and
      tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure
      to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood
      pressure change from baseline after 10 days of dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, must be of non-childbearing potential

          -  If male with female partner(s) of child-bearing potential must agree to use a
             medically acceptable method of contraception during the study and for 90 days after
             the last dose of study drug

          -  Body mass index (BMI) ≤35 kg/m^2

          -  Mild-to-moderate hypertension requiring treatment with one or more antihypertensive
             agents

          -  Receiving stable treatment for hypertension for at least 8 weeks prior to the start of
             dosing and continuing therapy for duration of study

          -  No clinically significant arrhythmias or clinically significant abnormality on
             electrocardiogram

          -  Nonsmoker and/or has not used nicotine or nicotine-containing products for at least
             approximately 6 months

        Exclusion Criteria:

          -  Any illness that might confound the results of the study or poses an additional risk

          -  History of stroke, chronic seizures, or major neurological disorder

          -  Clinically significant endocrine, gastrointestinal, hematological, hepatic,
             immunological, renal, respiratory, or genitourinary abnormalities or diseases

          -  Clinically significant cardiovascular disease or has active angina

          -  History of malignant neoplastic disease

          -  Taking 325 mg aspirin daily

          -  Taking 3 or more medications for the treatment of hypertension

          -  Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory
             drugs (NSAIDs)

          -  Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated
             beverages

          -  Has had major surgery, donated or lost 1 unit of blood or participated in another
             investigational study within 4 weeks

          -  Significant multiple and/or severe allergies

          -  Regular user of any illicit drugs or has a history of drug (including alcohol) abuse
             within approximately 2 years