A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 (8266-002)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01096160
First received: March 26, 2010
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

This study will evaluate the safety and tolerability of MK8266.


Condition Intervention Phase
Hypertension
Drug: MK8226 1 mg QD
Drug: MK8266 2 mg QD
Drug: MK8266 4 mg QD
Drug: MK8266 4 mg BID
Drug: MK8266 4 mg TID
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple 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 multiple oral doses of MK8266 measured by number of clinical and laboratory adverse experiences [ Time Frame: up to 24 hours post last dose ] [ Designated as safety issue: Yes ]
  • Change in Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 24 hours post dose on dosing Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Aortic Augmentation index (AIx) following multiple oral doses of MK8266 [ Time Frame: Dosing day 10 ] [ Designated as safety issue: No ]
  • Change in Cyclic Guanosine Monophosphate (cGMP) [ Time Frame: Baseline and 24 hours post dose on dosing Day 10 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - 1 mg QD
MK8266 1 mg once daily or placebo
Drug: MK8226 1 mg QD
MK8266 1 mg once daily for 10 days, as oral capsule
Other Name: MK8266
Drug: Comparator: Placebo
Placebo oral capsule (once, twice or three times daily) for 10 days
Experimental: Panel B - 2 mg QD
MK8266 2mg once daily or placebo
Drug: MK8266 2 mg QD
MK8266 2 mg once daily for 10 days, as oral capsule
Other Name: MK8266
Drug: Comparator: Placebo
Placebo oral capsule (once, twice or three times daily) for 10 days
Experimental: Panel C - 4 mg QD
MK8266 4 mg once daily or placebo
Drug: MK8266 4 mg QD
MK8266 4 mg once daily for 10 days, as oral capsule
Other Name: MK8266
Drug: Comparator: Placebo
Placebo oral capsule (once, twice or three times daily) for 10 days
Experimental: Panel D - 4 mg BID
MK8266 4 mg twice daily or placebo
Drug: MK8266 4 mg BID
MK8266 4 mg twice daily for 10 days, as oral capsule
Other Name: MK8266
Drug: Comparator: Placebo
Placebo oral capsule (once, twice or three times daily) for 10 days
Experimental: Panel E - 4 mg TID
MK8266 4 mg three times daily or placebo
Drug: MK8266 4 mg TID
MK8266 4 mg three times daily for 10 days, as oral capsule
Other Name: MK8266
Drug: Comparator: Placebo
Placebo oral capsule (once, twice or three times daily) for 10 days

  Eligibility

Ages Eligible for Study:   15 Years to 58 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male with essential hypertension (high blood pressure)
  • Subject is in good general health (with the exception of hypertension)
  • Subject is a non-smoker

Exclusion Criteria:

  • Subject has a history of stroke, chronic seizure, or major neurological disease
  • Subject has a functional disability that can interfere with rising from a seated position to the standing position
  • Subject has any history of a bleeding or clotting disorder
  • Subject has a history of cancer
  • Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • Subject consumes excessive amounts of alcohol or caffeinated beverages daily
  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: NCT01096160

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

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01096160     History of Changes
Other Study ID Numbers: MK-8266-002, 2010_522
Study First Received: March 26, 2010
Last Updated: January 27, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Merck Sharp & Dohme Corp.:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2014