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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:
ClinicalTrials.gov Identifier:
NCT01096160
First Posted: March 30, 2010
Last Update Posted: March 18, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266

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 ]
  • Change in Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 24 hours post dose on dosing Day 10 ]

Secondary Outcome Measures:
  • Change in Aortic Augmentation index (AIx) following multiple oral doses of MK8266 [ Time Frame: Dosing day 10 ]
  • Change in Cyclic Guanosine Monophosphate (cGMP) [ Time Frame: Baseline and 24 hours post dose on dosing Day 10 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 58 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096160


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01096160     History of Changes
Other Study ID Numbers: 8266-002
2010_522
First Submitted: March 26, 2010
First Posted: March 30, 2010
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases