Comparison Of Two Tablet Formulations Of SB-568859

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00470145

Enrollment

Registered

2007-05-07

Start date

2007-04-30

Completion date

2007-07-31

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

unmilled formulation,, micronised formulation, relative bioavailability,

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.

Interventions

DRUGSB-568859

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026