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

NCT00549653 | Completed Phase 1

• 1 other identifier: PM1106502
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atherosclerosis; Cardiovascular Disease

Keywords

GW856553,; drug-drug interactions,; rosuvastatin

Outcome Measures

Primary Outcomes (1)

• PK blood draws at days 14 and 28

  days 14 and 28

Secondary Outcomes (5)

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

  days 14, 15, 28

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

  days 14, 15, 28

• 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

• 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

• 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

Interventions

GW856553 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males, 18-55 years of age, inclusive
• Kg \>body weight \<120Kg
• Body Mass Index (BMI): 19-30
• Must be within 20% of the ideal weight based on height and body frame

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases

Interventions

6-(5-((cyclopropylamino)carbonyl)-3-fluoro-2-methylphenyl)-N-(2,2-dimethylprpyl)-3-pyridinecarboxamide

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 4, 2012

Record last verified: 2011-06

Locations

US (1)