A Single Dose Study of MK8266

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01025791
First received: December 3, 2009
Last updated: June 23, 2010
Last verified: June 2010

December 3, 2009
June 23, 2010
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 ] [ Designated as safety issue: Yes ]
  • Change in Aortic Augmentation index [ Time Frame: predose, 1, 3, 6, 12 and 24 hours postdose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01025791 on ClinicalTrials.gov Archive Site
change in heart rate [ Time Frame: predose through 12 hours postdose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Single Dose Study of MK8266
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: MK8266
    single rising oral doses of 0.1 to 24 mg of MK8266
    Other Name: MK8266
  • Drug: Placebo
    single dose administration of placebo oral capsule
  • Experimental: MK8266
    MK8266
    Intervention: Drug: MK8266
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01025791
2009_700, MK8266-001
No
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2010

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