A Study Investigating Blood Concentrations Of Rosuvastatin When Co-administered With GW856553 In Healthy Men

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: October 24, 2007
Last updated: May 31, 2012
Last verified: June 2011

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

Condition Intervention Phase
Cardiovascular Disease
Drug: GW856553
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • PK blood draws at days 14 and 28 [ Time Frame: days 14 and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The primary pharmacokinetic endpoints of interest are AUC(0-τ) and Cmax for rosuvastatin [ Time Frame: days 14, 15, 28 ] [ Designated as safety issue: No ]
  • The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin [ Time Frame: days 14, 15, 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW856553
    Other Name: GW856553

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549653

United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549653     History of Changes
Other Study ID Numbers: PM1106502
Study First Received: October 24, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
drug-drug interactions,

Additional relevant MeSH terms:
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014