Comparative Bioavailability of Oral and IV Dacomitinib (QBR113011)

• Research type

  Research Study

• Full title

  A Phase 1, Single Dose, Fixed Sequence Study to Estimate the Absolute Bioavailability of Dacomitinib (PF-00299804) by Comparing Oral to Intravenous Administration in Healthy Volunteers

• IRAS ID

  123762

• Contact name

  Philip Evans

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2013-000027-14

• Research summary

  The Sponsor is developing the study drug, dacomitinib, for the potential treatment of cancer. The study will investigate the comparative bioavailability (comparing the amount of study drug that is absorbed from the given dose) when given as a 45mg oral tablet compared to a 20 mg infusion into a vein. Fourteen'subjects will be enrolled in this study and each subject will receive 2 treatments. The first treatment will be a 45 mg single oral immediate release tablet. The second treatment will be a 20 mg intravenous infusion (into a vein) of the study drug which will last for 60 minutes. There will be a minimum 16 day 'washout' period between each treatment.

• REC name

  HSC REC B

• REC reference

  13/NI/0015

• Date of REC Opinion

  26 Mar 2013

• REC opinion

  Further Information Favourable Opinion