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Completed

NCT Number: NCT00470145

Comparison Of Two Tablet Formulations Of SB-568859

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Buffalo, New York, 14202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SB-568859

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2007
First posted
May 7, 2007
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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