NCT00470145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 4, 2012

Status Verified

February 1, 2011

First QC Date

May 3, 2007

Last Update Submit

May 31, 2012

Conditions

Atherosclerosis

Keywords

unmilled formulation,micronised formulationrelative bioavailability,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

SB-568859DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2007

First Posted

May 7, 2007

Study Start

April 1, 2007

Study Completion

July 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-02

Locations

US(1)