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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549653
• Other study ID #: PM1106502
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2007
• Last updated: May 31, 2012
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: June 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• GW856553

Locations

Country	Name	City	State
United States	GSK Investigational Site	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK blood draws at days 14 and 28		days 14 and 28	No
Secondary	The primary pharmacokinetic endpoints of interest are AUC(0-t) and Cmax for rosuvastatin		days 14, 15, 28	No
Secondary	The secondary pharmacokinetic endpoints of interest are Tmax and t1/2 for rosuvastatin		days 14, 15, 28	No
Secondary	Measurement of alanine aminotransferase (ALT) and maximum change from baseline in ALT in all subjects		days -1, 13, 14, 16, 18, 20, 22, 24, 26, 28, follow up	Yes
Secondary	Clinical safety data from spontaneous adverse event reporting, 12-lead ECG recording, vital sign measurement, nursing/physician observation and safety laboratory examination.		days -1, 13, 14, 16, 22, 26, 28, follow up	No
Secondary	Analysis of LPS induction of IL-1b, IL-6, IL-8 and TNFa, as well as additional biomarkers, as data permit.		day 1, 14, 21, 28	No