Comparison Of Two Tablet Formulations Of SB-568859

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Atherosclerosis

Treatments: Drug: SB-568859

Study type: Interventional

Funder types: Industry

Identifiers

NCT00470145

LP4110001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind