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
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 April 22, 2014