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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00615576 |
This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male smokers
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis |
Drug: SB656933 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Single Group Assignment, Pharmacokinetics Study |
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. |
Estimated Enrollment: | 16 |
Study Start Date: | March 2008 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CR2111256 |
Study First Received: | February 1, 2008 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00615576 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Male, Healthy Volunteer, Smoker, Cystic Fibrosis, Chronic Obstructive Lung Disease |
Lung Diseases, Obstructive Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Healthy Cystic fibrosis Pulmonary Disease, Chronic Obstructive |
Pathologic Processes |