Multiple rising doses of BI144807 over 14 days in asthmatics

• Research type

  Research Study

• Full title

  Safety, tolerability, pharmacokinetics, and exploratory pharmacodynamics of multiple rising doses of BI 144807 powder for oral drinking solution over a period of 14 days in otherwise healthy controlled asthmatic subjects in a randomised, double-blind, placebo-controlled trial

• IRAS ID

  107441

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Boehringer Ingelheim Pharma GmbH & Co. KG

• Eudract number

  2012-001615-23

• Research summary

  This multiple rising-dose trial will be randomised, double-blind, and placebo-controlled within dose groups. A total of 60 patients will participate in the trial according to 5 sequential groups of 12 patients each. Within each dose group 9 patients will receive the active drug and 3 will receive placebo. One dose is tested within each group. The primary objective of the current study is to investigate the safety and tolerability of BI 144807 in otherwise healthy, controlled asthmatic male and female subjects of non-child bearing potential following oral administration of repeated rising doses over 14 days. A secondary objective is the exploration of the pharmacokinetics and pharmacodynamics of BI 144807 after multiple dosing and to describe the pharmacokinetic/pharmacodynamic relationship.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0443

• Date of REC Opinion

  20 Jun 2012

• REC opinion

  Further Information Favourable Opinion