Comparison Of Two Tablet Formulations Of SB-568859

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470145
• Other study ID #: LP4110001
• Status: Completed
• Phase: Phase 1
• First received: May 3, 2007
• Last updated: May 31, 2012
• Start date: April 2007
• Est. completion date: July 2007

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• SB-568859

Locations

Country	Name	City	State
United States	GSK Investigational Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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