Clinical Trial: 28 Day Repeat Dose in Cystic Fibrosis Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibr

Brief Summary: The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis

Detailed Summary: This proof of mechanism study aims to evaluate the safety, tolerability and pharmacodynamics of SB-656933 following 28 days of daily administration of 20 and 50 mg SB-656933 in patients with CF compared to placebo. The primary endpoints of the study will be the effect of SB-656933 on safety and tolerability (adverse events, vital signs, clinical laboratory assessments, 12-lead electrocardiograms, and urinalysis) following 28 days of dosing. Secondary endpoints will include levels of neutrophil elastase in induced sputum and other sputum markers of inflammation (e.g. myeloperoxidase, total protein), induced sputum cells (i.e. total sputum neutrophil counts, percent sputum neutrophils) and sputum microbiology. Other assessments will include lung function measurements (spirometry); serum and plasma markers of inflammation (e.g. fibrinogen, CC-16, CRP, MMP8, MMP9, SP-D, and CXCL-8), quality of life questionnaire, and population pharmacokinetics parameters of SB-656933
Sponsor: GlaxoSmithKline

Current Primary Outcome: Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including, adverse events, vital signs, clinical laboratory assessments (hematology, chemistry, urinalysis, and VB-1),electrocardiographic (ECG)parameters,and exacerbation of CF [ Time Frame: 28 days and followup ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Sputum microbiology at 28 days as measured by bacterial colony counts of Pseudomonas aeruginosa and Staphylococcus aureus [ Time Frame: 28 days ]
  • Induced sputum neutrophil number (cells/mL) and percentage (%) [ Time Frame: 28 days ]
  • Induced sputum inflammatory markers: (e.g. but not limited to: NE, MPO, total protein). [ Time Frame: 28 days ]
  • FEV1 and FVC [ Time Frame: 28 days and followup ]
  • Serum and plasma markers of inflammation: (e.g. but not limited to: fibrinogen, CRP, CC-16, MMP8, MMP9, SP-D, CXCL8 (IL-8)) [ Time Frame: 28 days ]
  • Daily Respiratory Symptom Diary for Cystic Fibrosis (Self Reported Version (Exploratory)) [ Time Frame: 28 days ]
  • Plasma SB-656933 concentrations and pharmacokinetic parameters including area under the plasma drug concentration vs time curve (AUC(0-24), AUC(0-infinity)),maximum observed plasma drug concentration (Cmax)and time to maximum observed plasma drug consent [ Time Frame: 28 days ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: May 14, 2009
Date Started: September 2009
Date Completion:
Last Updated: January 27, 2017
Last Verified: January 2017