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A Single Dose Study of MK8266 (8266-001)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: December 3, 2009
Last updated: June 23, 2015
Last verified: June 2015
A three panel study, to determine if MK8266 given as a single dose is sufficiently safe and well tolerated. Panel A and B will consist of healthy young males and Panel C will consist of subjects with mild to moderate hypertension.

Condition Intervention Phase
Hypertension Drug: MK8266 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • safety and tolerability of single doses of MK8266 measured by number of clinical and laboratory adverse experiences [ Time Frame: 14 days after administration of last dose of study drug ]
  • Change in Aortic Augmentation index [ Time Frame: predose, 1, 3, 6, 12 and 24 hours postdose ]

Secondary Outcome Measures:
  • change in heart rate [ Time Frame: predose through 12 hours postdose ]

Enrollment: 25
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK8266
Drug: MK8266
single rising oral doses of 0.1 to 24 mg of MK8266
Placebo Comparator: Placebo
Drug: Placebo
single dose administration of placebo oral capsule


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • For Panel A and B Subject is a healthy male between 18 to 45 years of age. For Panel C subject is a male with essential hypertension between 18 to 55 years of age
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject has a history of stroke, chronic seizure or major neurological disorder
  • Subject has a disability that can interfere with rising from a sitting position to the standing position
  • Subject has a personal of family history of bleeding or clotting disorders
  • Subject has a history of cancer
  • Subject is unable to refrain from or anticipates the use of any prescription or nonprescription drug during the study
  • Subject consumes excessive amounts of caffeine or alcohol
  • Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
  Contacts and Locations
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Please refer to this study by its identifier: NCT01025791

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01025791     History of Changes
Other Study ID Numbers: 8266-001
Study First Received: December 3, 2009
Last Updated: June 23, 2015 processed this record on August 17, 2017