AtherosclerosisPhase 1NCT00470145
Comparison Of Two Tablet Formulations Of SB-568859
A Phase 1 study testing SB-568859 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- SB-568859
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Atherosclerosis
- Being tested
- SB-568859
- Keywords
- unmilled formulation,, micronised formulation, relative bioavailability,
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-568859Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study startApr 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470145
- Sponsor's protocol ID
- LP4110001
- Status last verified
- Feb 2011
- First submitted
- 3 May 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00470145
- Acronym / sponsor ID
- LP4110001
- Conditions
- Atherosclerosis
- Keywords
- unmilled formulation,, micronised formulation, relative bioavailability,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-568859 | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SB-568859 in people with Atherosclerosis, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.