Comparison Of Two Tablet Formulations Of SB-568859

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00470145
First received: May 3, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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 Intervention Phase
Atherosclerosis
Drug: SB-568859
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 28
Study Start Date: April 2007
Study Completion Date: July 2007
Intervention Details:
    Drug: SB-568859
    Other Name: SB-568859
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00470145

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00470145     History of Changes
Other Study ID Numbers: LP4110001
Study First Received: May 3, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014