AtherosclerosisPhase 1NCT00549653
A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men
A Phase 1 study testing GW856553 in people with Atherosclerosis and Cardiovascular Disease, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Cardiovascular Disease
- What is being tested?
- GW856553
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult males, 18-55 years of age, inclusive
- 50Kg >body weight <120Kg
- Body Mass Index (BMI): 19-30
- Must be within 20% of the ideal weight based on height and body frame
Who cannot join
- Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- Positive HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, or other chronic hepatic disorders at screening.
- Subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, urinary track infections, or any active diseases, including tuberculosis or a history of active tuberculosis.
- Subjects with any acute infection, symptoms suggestive of sinusitis or significant trauma (burns, fractures).
- History of alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of 80 proof distilled spirits) within 6 months of screening.
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- Positive urine drug (including cotinine) and/or alcohol at screening.
- A history of smoking within the 3 months prior to screening.
- Use of prescription or non-prescription drugs, including (but not limited to) vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential drug inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication. An exception is acetaminophen which is allowed at doses of ≤ 2g/day.
- Participation in a clinical study where the subject has received a drug or new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject has been exposed to more than four new chemical entities within 12 months prior to the first day of dosing.
- Consumption of any fruit juices (including grapefruit juice) within 7 days prior to the first dose of study medication.
- A history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology.
- History of increased liver function tests (ALT, AST) above upper limit of normal in the past 6 months and/or liver function tests (bilirubin, ALT, AST) above upper limit of normal at Screening.
- A known history of Gilbert's Syndrome.
- History of myopathy or rhabdomyolysis.
- QTc interval > 450msec.
- An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception, such as: an intrauterine devise (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if the woman could become pregnant from the first dose of study medication until completion of follow-up procedures.
- Donation of blood in excess of 500 mL within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Hypersensitivity to rosuvastatin or any component of the rosuvastatin formulation utilised in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Blind, Repeat Dose, Placebo-controlled, Single-period, Parallel Group Study to Investigate the Safety, Tolerability and Potential Pharmacokinetic Interactions Between GW856553 and Rosuvastatin (10mg), When Co-administered in Healthy Adult Male Subjects
This study is being conducted to provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
- Conditions
- Atherosclerosis, Cardiovascular Disease
- Being tested
- GW856553
- Keywords
- GW856553,, drug-drug interactions,, rosuvastatin
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases
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.
PK blood draws at days 14 and 28
Measured: days 14 and 28
Secondary outcomes (5)
The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin
Measured: days 14, 15, 28
The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin
Measured: days 14, 15, 28
Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects
Measured: days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up
Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination.
Measured: days -1, 13, 14, 16, 22, 26, 28, follow up
Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit.
Measured: day 1, 14, 21, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 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
- NCT00549653
- Sponsor's protocol ID
- PM1106502
- Status last verified
- Jun 2011
- First submitted
- 24 Oct 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 Randomized, Single Blind, Repeat Dose, Placebo-controlled, Single-period, Parallel Group Study to Investigate the Safety, Tolerability and Potential Pharmacokinetic Interactions Between GW856553 and Rosuvastatin (10mg), When Co-administered in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT00549653
- Acronym / sponsor ID
- PM1106502
- Conditions
- Atherosclerosis, Cardiovascular Disease
- Keywords
- GW856553,, drug-drug interactions,, rosuvastatin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Oct 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 provide initial safety and tolerability data as well as to provide PK data on potential interactions when GW856553 and rosuvastatin are co-administered in healthy male adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adult males, 18-55 years of age, inclusive
- 50Kg >body weight <120Kg
- Body Mass Index (BMI): 19-30
- Must be within 20% of the ideal weight based on height and body frame
Key exclusion criteria (21 listed)
- Any medical history or clinically relevant abnormality identified on the screening medical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
- Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with chronic inflammation (e.g. Inflammatory Bowel Disease).
- Positive HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody, or other chronic hepatic disorders at screening.
- Subjects with chronic infections such as gingivitis, periodontitis, prostatitis, gastritis, urinary track infections, or any active diseases, including tuberculosis or a history of active tuberculosis.
- Subjects with any acute infection, symptoms suggestive of sinusitis or significant trauma (burns, fractures).
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
PK blood draws at days 14 and 28
Time frame: days 14 and 28
5 secondary outcomes
The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin
Time frame: days 14, 15, 28
The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin
Time frame: days 14, 15, 28
Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects
Time frame: days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up
Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination.
Time frame: days -1, 13, 14, 16, 22, 26, 28, follow up
Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit.
Time frame: day 1, 14, 21, 28
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 GW856553 in people with Atherosclerosis and Cardiovascular Disease, 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 4 inclusion and 21 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?
PK blood draws at days 14 and 28 (time frame: days 14 and 28). 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.