Saracatinib Trial TO Prevent FOP

Exclusion Criteria

• •1. Not willing to strictly adhere to the reproductive restrictions as defined in section 5.4
• •2. Women who are pregnant or breast-feeding (from the time 3 months prior to 4 weeks after completion of participation in the study)
• •3. The presence of significant concomitant illness or history of significant illness such as cardiac, respiratory, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic, lymphatic disease, or infectious disease, that might confound the results of the study or pose additional risk to the patient;
• •4. Evidence of active bleeding (including hematuria or hematochezia,) acute or chronic gastrointestinal illness, inflammatory bowel disease, or mucositis
• •5. Malignant disease / cancer requiring treatment in the past 3 years (except some primary non melanoma skin cancer);
• •6. Severely impaired renal function defined as estimated glomerular filtration rate \<30 mL/min/1.73 m2 calculated by the Modification of Diet in Renal Disease equation;
• •7. Showing uncontrolled diabetes mellitus with an HbA1C \> 9%;
• •8. Significant viral illness or active infections at screening or randomisation; Subjects should not have subacute or acute fevers of \>101 degrees F at time of screening or randomisation
• •9. Evidence of prolonged QT interval at screening or randomization (defined as QTc of \>450 ms) .or known congenital long-QT syndrome.
• •10. Neutropenia defined as an absolute neutrophil count of \<1,500/µl,
• •11. Thrombocytopenia defined as platelet count \<100 × 103/µl,
• •12. Current blood clotting or bleeding disorder, or significantly abnormal INR-prothrombin time or partial thromboplastin time at screening, or clinically significant abnormalities in other screening laboratories, including significant abnormalities in vitamin B12 or thyroid function tests would be cause for exclusion.-
• •13. Abnormal liver function test results defined as aspartate aminotransferase (AST) \>2.0 x upper limit of normal (ULN); alanine aminotransferase (ALT) \>2.0 x ULN; and / or total bilirubin \>1.5 x ULN;
• •14. Known allergy or intolerance to AZD0530 or any excipients used in the investigational medicinal products.
• •15. Simultaneous participation in another interventional clinical study or a non-interventional study with imaging measures or invasive procedures (eg. collection of blood or tissue samples); Participation in the FOP Connection Registry (www.fopconnection.org) or other studies in which patients completed study questionnaires are possible.
• •16. Treatment with another investigational or drug that might interfere with HO formation and the interpretation of the study drug in the last 90 days
• •17. Current use or history of regular alcohol consumption exceeding 14 units/week (6 glasses of 13.0% wine (175ml), 6 pints of 4.0% lager or ale (568ml), 5 pints of 4.5% cider (568 ml) or 14 glasses of 10.0% spirits (25ml)) within 6 months of screening.
• •18. Currently active metabolic bone disease, other than FOP.