Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers

Summary

The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.

Timeline

Start

2008-10

Primary completion

2008-12

Completion

2008-12

Publications

• Background Russell T, Riley SP, Cook JA, Lalonde RL. A perspective on the use of concentration-QT modeling in drug development. J Clin Pharmacol. 2008 Jan;48(1):9-12. doi: 10.1177/0091270007311115. No abstract available.
• Background Garnett CE, Beasley N, Bhattaram VA, Jadhav PR, Madabushi R, Stockbridge N, Tornoe CW, Wang Y, Zhu H, Gobburu JV. Concentration-QT relationships play a key role in the evaluation of proarrhythmic risk during regulatory review. J Clin Pharmacol. 2008 Jan;48(1):13-8. doi: 10.1177/0091270007307881.
• Background Bloomfield D, Krishna R. Commentary on the clinical relevance of concentration/QTc relationships for new drug candidates. J Clin Pharmacol. 2008 Jan;48(1):6-8. doi: 10.1177/0091270007312257. No abstract available.

Drugs

Indications