Safety, Pharmacodynamics, and Pharmacokinetics of Different Dosing Regimens of MK-8266 in Participants With Hypertension (MK-8266-008)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F
Intervention description: MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.; MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.; Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 31.0
Sex: Male
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: High blood pressure

Summary:

      This was designed as a two part study comprising sequential double-dummy, placebo controlled
      3-period randomized crossover studies. The study will evaluate the safety, tolerability,
      pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only
      Part I of the study was completed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has essential hypertension who is in grade 1 or 2 hypertension according
             to the European Society of Hypertension (ESH) as delineated in the European Society of
             Cardiology (ESC) 2007 guidelines, i.e. systolic blood pressure values of 140-179 and
             diastolic blood pressure values of 90-109 on at least 3 occasions prior to the study.

          -  Otherwise healthy participants with grade 1 or 2 arterial hypertension who are treated
             with a single antihypertensive drug and meet the above blood pressure criteria may be
             enrolled at the discretion of the investigator

          -  Participant is generally in good health with the exception of hypertension

          -  Participant is a nonsmoker and/or has not used nicotine or nicotine-containing
             products for 6 months

        Exclusion Criteria:

          -  Participant has a history of any illness that might confound the results of the study
             or pose and additional risk to the participant if they take part in the study

          -  Participant has a history of stroke, chronic seizures, or major neurological disorder

          -  Participant has a disability that can interfere with rising from a semi-recumbent
             position to the standing position

          -  Participant has a personal or family history of a bleeding or clotting disorder

          -  Participant has a history of frequent nosebleeds or recurrent or active gingivitis

          -  Participant has a history of cancer, except 1) certain skin cancers; 2) cancer
             successfully treated more than 10 years prior to the study that has not recurred; or,
             3) participants who are unlikely to have a recurrence during the study

          -  Participant has a history of cardiac disease including but not limited to heart valve
             disease or evidence of secondary cardiac damage

          -  Participant is categorized as class II or greater according to the New York Heart
             Association (NYHA) functional classification for heart failure

          -  Participant is unable to refrain from use of prescription or non-prescription drugs or
             herbal remedies (such as St. John's Wort) during the study

          -  Participant anticipates using phosphodiesterase (PDE5) inhibitors [sildenafil
             (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®)] during the study

          -  Participant consumes excessive amounts of alcohol (more than 3 drinks per day) or
             caffeine (more than 6 servings a day)

          -  Participant has had major surgery, donated or lost 1 unit of blood, or participated in
             another investigational within 4 weeks prior to the study

          -  Participant has a history of multiple and/or severe allergies, or has had an
             anaphylactic reaction or intolerance to any drugs or food