Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677
Status:
Completed
Trial end date:
2008-09-23
Target enrollment:
Participant gender:
Summary
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.