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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.
Show all 21Show fewer
  • 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.

United States1 site

  • GSK Investigational Site

    Dallas, Texas, 75247

Other trials in United States

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

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.

  1. PK blood draws at days 14 and 28

    Measured: days 14 and 28

Secondary outcomes (5)

  1. The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin

    Measured: days 14, 15, 28

  2. The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin

    Measured: days 14, 15, 28

  3. 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

  4. 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

  5. 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.

  1. First posted26 Oct 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT00549653.

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; AzTrials last refreshed its copy on 6 Nov 2026.

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