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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00549653
First received: October 24, 2007
Last updated: May 31, 2012
Last verified: June 2011
  Purpose

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
Atherosclerosis
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
  Eligibility

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

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

Locations
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75247
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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:
GW856553,
drug-drug interactions,
rosuvastatin

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

ClinicalTrials.gov processed this record on April 14, 2014