Repeat Dose Study in Male Healthy Volunteer Smokers
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|ClinicalTrials.gov Identifier: NCT00615576|
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: SB-656933 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|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|
|Actual Study Start Date :||March 26, 2008|
|Actual Primary Completion Date :||July 24, 2008|
|Actual Study Completion Date :||July 24, 2008|
Experimental: Subjects receiving SB-656933
Eligible subjects will be randomized to receive once daily doses of 100 milligrams of SB- 656933 for 14 days.
SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.
Placebo Comparator: Subjects receiving placebo
Eligible subjects will be randomized to receive placebo for 14 days.
A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
- -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 ]
- - 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) [ Time Frame: Up to Day 28 ]
- Fluorocytometric quantitation of CXCL1-induced CD11b expression on peripheral blood neutrophils in ex-vivo assay. [ Time Frame: Up to Day 14 ]
- Neutrophil shape change in response to stimulation with CXCL-1 in whole blood ex-vivo gated autofluorescence forward scatter (GAFS) assay. [ Time Frame: Up to Day 14 ]
- Looking at the actual sample size data to determine a larger theoretical population. [ Time Frame: Up to Day 14 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615576
|GSK Investigational Site|
|London, United Kingdom, NW10 7NS|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|