Comparison Of Two Tablet Formulations Of SB-568859

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. Identifier: NCT00470145
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

Brief Summary:
SB-568859 is a medication that is being developed for the treatment of atherosclerosis (hardening of the arteries). The purpose of this study is to see if there is a difference in how the human body takes up the study drug depending on how the study drug is made. This study will compare SB-568859 tablets that are made in 2 different ways. This is not a treatment study.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: SB-568859 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomised, Single Blind, 2 Period, Crossover Study to Compare the Single Dose Pharmacokinetics and Tolerability of Formulations Containing Unmilled and Micronised SB-568859 in Healthy Adults
Study Start Date : April 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Primary Outcome Measures :
  1. Comparison of the amount of SB-568859 found in the blood over a period of 6 days after a single dose of each of the two types of tablets [ Time Frame: 6 days ]

Secondary Outcome Measures :
  1. Assessment of the safety and tolerability of SB-568859 after a single dose of each of the two types of tablets based on blood and urine tests, vital signs, electrocardiograms and reporting of side effects over a period of 6 days after each dose. [ Time Frame: 6 days ]

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:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy men and sterile women between 18 and 50 years old
  • Body weight greater than 50 pounds and a body mass index between 19 and 31
  • Normal electrocardiogram

Exclusion criteria:

  • No history of asthma or severe allergic reactions
  • No history of or current drug use
  • No Hepatitis or HIV/AIDS
  • No excessive alcohol use
  • No smoking or tobacco use
  • No use of prescription drugs, over-the-counter drugs or vitamins within 7 days
  • No use of herbal supplements within 14 days
  • No treatment with an investigational drug within 30 days.
  • No treatment with 4 or more investigational drugs in the last 12 months
  • No grapefruit or grapefruit juice in the last 7 days
  • No donation of blood in the last 8 weeks
  • No history of allergy to heparin
  • No history of liver or gall bladder disease
  • Unwillingness to use contraception

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 identifier (NCT number): NCT00470145

United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00470145     History of Changes
Other Study ID Numbers: LP4110001
First Posted: May 7, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: February 2011

Keywords provided by GlaxoSmithKline:
unmilled formulation,
micronised formulation
relative bioavailability,

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases