Last updated: 11/04/2018 08:54:46
Comparison Of Two Tablet Formulations Of SB-568859
GSK study ID
LP4110001
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
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
Timeframe: 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.
Timeframe: 6 days
Interventions:
Enrollment:
28
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atherosclerosis
Product
SB568859
Collaborators
Not applicable
Study date(s)
April 2007 to July 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- 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
- No history of asthma or severe allergic reactions
- No history of or current drug use
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Buffalo, New York, United States, 14202
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-02-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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