A Single Dose Study of MK8266 (8266-001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01025791
First received: December 3, 2009
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266

Resource links provided by NLM:


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 ] [ 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 ]

Secondary Outcome Measures:
  • change in heart rate [ Time Frame: predose through 12 hours postdose ] [ Designated as safety issue: No ]

Estimated 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
MK8266
Drug: MK8266
single rising oral doses of 0.1 to 24 mg of MK8266
Other Name: MK8266
Placebo Comparator: Placebo
Placebo
Drug: Placebo
single dose administration of placebo oral capsule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025791

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01025791     History of Changes
Other Study ID Numbers: 8266-001, MK8266-001, 2009_700
Study First Received: December 3, 2009
Last Updated: July 3, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014