Repeat Dose Study in Male Healthy Volunteer Smokers
This study has been completed.
Information provided by:
First received: February 1, 2008
Last updated: October 14, 2010
Last verified: October 2010
This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male smokers
Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SB-656933 Following 14 Days Repeat Dosing in Healthy Male Smokers.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- -what the body does to the drug over a 17 day of dosing with 100mg of SB656933. -Safety of SB-656933: Adverse events, blood pressure, heart rate, electrocardiogram, epididymal ultrasound and lab tests [ Time Frame: 17 days ]
- -what the body does to the drug over a 17 day of dosing with 100mg of SB656933 by taking PK samples at: [ Time Frame: pre-dose and at 0.5,1,2,3,4,6,8,12 and 24 hours post-dose on days 1 and 14; pre-dose on Day7. Additional samples at 32, 48 and 72 hours post-dose wil ]
- -Safety of SB-656933: Adverse events every day for entire study period: blood pressure , heart rate and temperature [ Time Frame: taken pre-dose, 30min, 1hr, and 2hr on Day1, Day2, Day7 and Day14 (supine only); ]
- electrocardiogram [ Time Frame: pre-dose, 2hr and 4 hr on Day1 ]
Secondary Outcome Measures:
- - Looking at the actual sample size data to determine a larger theoretical population. -What the drug does to the body when present at its lowest level on day 14 as compared before drug given. [ Time Frame: 17 days ]
- Safety and tolerability of SB-656933 in subjects with cystic fibrosis, including adverse events, vital signs, clinical laboratory assessments, electrocardiographic (ECG) parameters, and lung function (FVC, FEV1)
- Fluorocytometric quantitation of CXCL1-induced CD11b expression on peripheral blood neutrophils in ex-vivo assay.
- Neutrophil shape change in response to stimulation with CXCL-1 in whole blood ex-vivo gated autofluorescence forward scatter (GAFS) assay.
- Looking at the actual sample size data to determine a larger theoretical population.
- What the drug does to the body when present at its lowest level on day 14 as compared before drug given. [ Time Frame: on day 14 ]
|Study Start Date:||March 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Other Name: SB656933
Contacts and Locations