Comparison Of Two Tablet Formulations Of SB-568859

Phase 1

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT00470145
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Study Completion: 2007-07
• Status Verified: 2011-02
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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	6 days

Secondary Outcome Measures

Name	Time	Method
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.	6 days

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Buffalo, New York, United States