A Single Dose Study of MK8266 (8266-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025791
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : June 24, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: MK8266 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
  2. Change in Aortic Augmentation index [ Time Frame: predose, 1, 3, 6, 12 and 24 hours postdose ]

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01025791

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01025791     History of Changes
Other Study ID Numbers: 8266-001
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015