Back to resultsComparison Of Two Tablet Formulations Of SB-568859
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB-568859
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring unmilled formulation,, micronised formulation, relative bioavailability,
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00470145
Brief Title
Comparison Of Two Tablet Formulations Of SB-568859
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
unmilled formulation,, micronised formulation, relative bioavailability,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
SB-568859
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14202
Country
United States
12. IPD Sharing Statement
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Comparison Of Two Tablet Formulations Of SB-568859
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