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.

December 3, 2009
December 4, 2009
June 24, 2015
November 2009
May 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01025791 on Archive Site
change in heart rate [ Time Frame: predose through 12 hours postdose ]
Same as current
Not Provided
Not Provided
A Single Dose Study of MK8266 (8266-001)
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266
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.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: MK8266
    single rising oral doses of 0.1 to 24 mg of MK8266
  • Drug: Placebo
    single dose administration of placebo oral capsule
  • Experimental: MK8266
    Intervention: Drug: MK8266
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP