Comparison Of Two Tablet Formulations Of SB-568859

GlaxoSmithKline28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atherosclerosis

Interventions

SB-568859DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Buffalo, New York, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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