A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: MK-8226 BID, 1 mg; MK-8266 BID, 1.8 mg; MK-8266 TID, 1.8 mg; MK-8266 TID, 2.4 mg; MK-8266 TID, 2.4 mg; Placebo BID (Panel A); Placebo BID (Panel B); Placebo TID (Panel C); Placebo TID (Panel D); Placebo TID (Panel E)
Intervention description: MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.; MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.; MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.; MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.; MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.; Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.; Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.; Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.; Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.; Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Hypertension

Summary:

      This study evaluated adverse events (AEs), study discontinuation due to AEs, and
      pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is male with essential hypertension (high blood pressure)

          -  Participant is in good general health (with the exception of hypertension)

          -  Participant has a Body Mass Index (BMI) <= 33 kg/m^2 at the Screening visit

          -  Participant has a platelet count >= 150,000 cu/mL at the Screening visit

          -  Participant has a positive AIx at the Screening visit

        Exclusion Criteria:

          -  Participant has a history of stroke, chronic seizure, or major neurological disease

          -  Participant has a functional disability that can interfere with rising from a seated
             position to the standing position

          -  Participant has any history of a bleeding or clotting disorder

          -  Participant has a history of cancer

          -  Participant is unable to refrain from or anticipates the use of any prescription or
             non-prescription medication

          -  Participant consumes excessive amounts of alcohol or caffeinated beverages daily