CompletedNCT00470145Updated Jun 4, 2012

Comparison Of Two Tablet Formulations Of SB-568859

A Phase 1 interventional study of SB-568859 in Atherosclerosis, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-04.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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 studied

Atherosclerosis

Browse trials for

Atherosclerosis 1,567

Keywords

unmilled formulation,
micronised formulation
relative bioavailability,

In context

Atherosclerosis

1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.

This study's enrollment of 28 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.

Browse Atherosclerosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single
Enrollment: 28 participants (actual)

Interventions

DrugSB-568859

What researchers measure

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

Study locations

1 site

GSK Investigational Site
Buffalo, New York 14202, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00470145
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: May 7, 2007
Start date: Apr 2007
Completion: Jul 2007
Last update: Jun 4, 2012

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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