A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)

A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8266

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

This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.

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