Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677
This study is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Individual subjects in each cohort will have up to 3 treatment periods. In each treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo. Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort, there will be a minimum wash out period of at least 10 days. In this period safety and tolerability data will be collected prior to dose to the next level.After safety review meetings between the site and the sponsor following the administration of the 500 ug dose, it was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each subject in Cohort III will undergo a screening visit, one treatment period, and a follow up visit.
Pulmonary Disease, Chronic Obstructive
Chronic Obstructive Pulmonary Disease (COPD)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Single-centre, Randomized, Double-blind , Placebo Controlled, Dose Escalating Cross-over Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Inhaled Doses of GSK610677 and Placebo in Healthy Male Subjects|
- Blood samples over a period of 48 hours.
- Safety parameters over a period of the study, including ECG, Telemetry and vital sign. Continuous adverse event monitoring from dosing until study conclusion and follow up, 14-21 days after last dose. [ Time Frame: dosing until study conclusion and follow up, 14-21 days after last dose ]
- Plasma GSK610677 and GSK1437357 concentrations
|Study Start Date:||May 2008|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|