Comparison Of Two Tablet Formulations Of SB-568859

NCT ID: NCT00470145

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-07-31

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.

Conditions

Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

SB-568859

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Buffalo, New York, United States

Countries

United States

Other Identifiers

LP4110001

Identifier Type: -

Identifier Source: org_study_id