Comparative Bioavailability of Oral and IV PD-0332991 (QBR115052)

• Research type

  Research Study

• Full title

  A Phase 1, Single Dose, Fixed Sequence, 2-period Cross-over Absolute Oral Bioavailability Study in Healthy Volunteers Comparing Oral to Intravenous Administration of PD-0332991

• IRAS ID

  124582

• Contact name

  Philip Evans

• Sponsor organisation

  Oncology Late Phase Developement

• Eudract number

  2013-000294-75

• Research summary

  The study drug PD-0332991, is currently being tested by Pfizer for the treatment of cancer. In this study, Pfizer wishes to determine the proportion of an oral capsule dose that is taken up from the digestive tract into the body compared with that taken up by an intravenous dose. This will be done by taking a capsule given orally during the first treatment period and then receiving the drug as a slow intra-venous (IV) (within the vein) infusion during the second treatment period about 10 days later. The amount of drug detected in the blood will be measured after receiving each dose and the results compared.Fourteen'subjects will be enrolled in this study and each subject will receive 2 treatments with a 'washout' period of at least 10 days between treatments. The first treatment will be a 125 mg single oral dose of PD-0332991 administered as an immediate release hard capsule. The second treatment will be a 50 mg intravenous infusion (into a vein) of the study drug which will last for approximately 4 hours.

• REC name

  HSC REC A

• REC reference

  13/NI/0025

• Date of REC Opinion

  28 Mar 2013

• REC opinion

  Further Information Favourable Opinion