The Effects of Coadministration of Fostamatinib and Oral Contraceptive

• Research type

  Research Study

• Full title

  A Single-blind, Placebo-controlled, 2-period, Fixed Sequence Study to Determine the Effects of Coadministration of Fostamatinib 100 mg Twice Daily and an Oral Contraceptive in Healthy Female Subjects

• IRAS ID

  71680

• Contact name

  James Ritter

• Sponsor organisation

  AstraZeneca Pharmaceuticals

• Eudract number

  2010-024452-28

• Research summary

  Fostamatinib is an unlicensed drug being developed for the treatment of rheumatoid arthritis. Fostamatinib weakly inhibits an enzyme in the liver that breaks down other drugs and hormones, including oral contraceptives (OCs). OC failure and unplanned pregnancy can occur in women treated with drugs that affect these enzymes. We do not expect that fostamatinib will have this effect, but it is not possible to be completely confident of this without testing for the possibility. Up to 56 healthy female volunteers will be enrolled onto the study. The study will consist of a screening period, followed by 2 treatment periods (28 days each) of oral contraceptive (Microgynon© 30) one with and one without fostamatinib. During one of the treatment periods subjects will receive fostamatinib and during the other period they will receive placebo (dummy tablets). Blood tests will be performed to assess the effect of each drug on the other one to investigate if there is an interaction.The study will be conducted at Quintiles Drug Research Unit at Guy's Hospital, London

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/31

• Date of REC Opinion

  2 Mar 2011

• REC opinion

  Further Information Favourable Opinion