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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
ClinicalTrials.gov Identifier:
NCT01096160
First received: March 26, 2010
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096160

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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: Directorate general for the protection of Public health: Medicines

Keywords provided by Merck:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013