Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT00517543
A Study to Examine the Effect of Particle Size on Bioequivalence and Bioavailability
A Phase 1 study testing GW856553 in people with Chronic Obstructive Pulmonary Disease (COPD) and Rheumatoid Arthritis, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is being conducted to measure the amount of study drug that is in your blood after you receive a different type of tablet in each of four study visits. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis
- What is being tested?
- GW856553
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males and females between 18 and 60 years of age, inclusive. Whether a subject is "healthy" will be determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
- To be eligible, female subjects must have a negative pregnancy test (i.e. serum hCG test) and be of:
- non-childbearing potential (i.e. physiologically incapable of becoming pregnant). This includes pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy, or documented hysterectomy - tubal ligation is not sufficient.
- childbearing potential and agrees to commit to two of the protocol-approved methods of contraception, when used consistently and in accordance with both the product label and the instructions of a physician (and as listed in Appendix 3).
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptive, inject able progesterone, or sub dermal implant if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until completion of follow up procedures.
- Body weight >/ 50 kg (110 pounds) for men and >/ 45 kg (99 pounds) for women and body mass index (BMI) between 19 and 31.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within reference range at screening.
- Signed and dated written informed consent prior to admission to the study. The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
Who cannot join
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12 lead) judged by the Investigator and /or GSK medical monitor to potentially introduce additional risk factors and/or interfere with the study procedures.
- Significant cardiac, pulmonary, metabolic, renal, hepatic, neurological, psychiatric, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
- History of Gilbert's syndrome.
- Elevated blood pressure or history of elevated blood pressure considered clinically significant by the Investigator.
- History of increased liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST) above 1.5 x upper limit of normal (UNL) in the past 6 months.
- History of alcohol/drug abuse or dependence within 12 months of the study.
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- The subject has a positive pre-study drug or alcohol screen.
- Positive for Hepatitis C antibody, Hepatitis B surface antigen or HIV.
- History of regular alcohol consumption averaging > 7 drinks/week for women or > 14 drinks/week for men. One drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine; or 12 ounces (360 mL) of beer; or 1.5 ounces (45 mL) of 80 proof distilled spirits within 6 months of screening.
- Urinary cotinine levels indicative of smoking. History or regular use of tobacco or nicotine-containing products within 6 months prior to screening.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort, kava, ephedra (ma huang), gingko biloba, DHEA, yohimbe, saw palmetto, ginseng and red yeast rice) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Where participation in this study would result in donation of blood in excess of 500 mL within a 56-day period.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing.
- Female subjects who are nursing, pregnant, or plan to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553
This study is being conducted to measure the amount of study drug that is in your blood after you receive a different type of tablet in each of four study visits.
- Being tested
- GW856553
- Keywords
- inflammation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Arthritis, Rheumatoid, Atherosclerosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW856553Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
1) to demonstrate bioequivalence of four different particle sizes by assay of blood from dosing through 72 hours post dose in each of four study periods
Secondary outcomes (2)
1) determine/compare relative bioavailability by assay of blood (dosing to 72 hr in 4 study periods) 2) assess safety/tolerability of single oral doses thru AE reporting; vs & ECG monitoring from per 1 dosing thru study f/u
determine the relative bioavailability of a single oral dose of 15 mg GW856553 in healthy subjects using a tablet with a particle size of > 20 microns (a milled formulation) compared to tablets with particle sizes of 2 microns, 4 microns, and 6 microns.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517543
- Sponsor's protocol ID
- 109385
- Status last verified
- Oct 2010
- First submitted
- 16 Aug 2007
- Last updated
- 14 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553
- ClinicalTrials.gov ID
- NCT00517543
- Acronym / sponsor ID
- 109385
- Keywords
- inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Aug 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.
This study is being conducted to measure the amount of study drug that is in your blood after you receive a different type of tablet in each of four study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult males and females between 18 and 60 years of age, inclusive. Whether a subject is "healthy" will be determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
- To be eligible, female subjects must have a negative pregnancy test (i.e. serum hCG test) and be of:
- Male subjects must agree to abstain from or use a condom during sexual intercourse with pregnant or lactating females; or use a condom/spermicide, in addition to having their female partner use another form of contraception, such as an IUD, diaphragm with spermicide, oral contraceptive, inject able progesterone, or sub dermal implant if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of the first dose of study medication until completion of follow up procedures.
- Body weight >/ 50 kg (110 pounds) for men and >/ 45 kg (99 pounds) for women and body mass index (BMI) between 19 and 31.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin within reference range at screening.
Key exclusion criteria (15 listed)
- Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12 lead) judged by the Investigator and /or GSK medical monitor to potentially introduce additional risk factors and/or interfere with the study procedures.
- Significant cardiac, pulmonary, metabolic, renal, hepatic, neurological, psychiatric, or gastrointestinal conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial.
- History of Gilbert's syndrome.
- Elevated blood pressure or history of elevated blood pressure considered clinically significant by the Investigator.
- History of increased liver function tests [alanine aminotransferase (ALT), aspartate aminotransferase (AST) above 1.5 x upper limit of normal (UNL) in the past 6 months.
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 |
|---|---|---|
| GW856553 | Drug | – |
Primary outcome
1) to demonstrate bioequivalence of four different particle sizes by assay of blood from dosing through 72 hours post dose in each of four study periods
2 secondary outcomes
1) determine/compare relative bioavailability by assay of blood (dosing to 72 hr in 4 study periods) 2) assess safety/tolerability of single oral doses thru AE reporting; vs & ECG monitoring from per 1 dosing thru study f/u
determine the relative bioavailability of a single oral dose of 15 mg GW856553 in healthy subjects using a tablet with a particle size of > 20 microns (a milled formulation) compared to tablets with particle sizes of 2 microns, 4 microns, and 6 microns.
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 14 Oct 2010.
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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, MD 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 GW856553 in people with Chronic Obstructive Pulmonary Disease (COPD) and Rheumatoid Arthritis, 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 8 inclusion and 15 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 14 Oct 2010. 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?
1) to demonstrate bioequivalence of four different particle sizes by assay of blood from dosing through 72 hours post dose in each of four study periods. 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 14 Oct 2010; AzTrials last refreshed its copy on 29 Oct 2026.