Saracatinib Trial TO Prevent FOP

Inclusion Criteria:

1. Male or female aged 18-65 with a clinical diagnosis of FOP at screening, includingcongenital malformation of the great toes and a history of spontaneous orinjury-induced heterotopic ossification (HO), and have a confirmed classic FOPphenotype by the documentation of an ACVR1R206H/+ or variant genomic sequence.
2. Female participants who are women of child-bearing potential will be required touse a highly effective method of contraception as defined in section 5.4, incombination with a condom or diaphragm or cervical/vault caps with spermicidalfoam/gel/film/suppository), from the time of enrolment until 4 weeks after finaldose of study drug, unless practicing true sexual abstinence as defined insection 5.4.
3. Male participants will be required to avoid procreative sexual intercourse withwomen of child-bearing potential from time of enrollment until 4 weeks afterfinal dose of study drug through use of highly effective contraceptive methods.Male participants with a pregnant female partner will be required to use a condomfor the duration of the study and for 4 weeks final dose of study drug. Malestudy participants will not be permitted to donate sperm for from the time ofenrolment and until 4 weeks after final dose of study drug.
4. Participants will have to be able to understand and complete study and willing to signinformed consent (IC). They have to be able to attend and comply with the study visitsand related activities, adhere to all study-related restrictions, and able to undergoprocedures such as PET and CT imaging.

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 weeksafter completion of participation in the study)
3. The presence of significant concomitant illness or history of significant illness suchas cardiac, respiratory, renal, rheumatologic, neurologic, psychiatric, endocrine,metabolic, lymphatic disease, or infectious disease, that might confound the resultsof the study or pose additional risk to the patient;
4. Evidence of active bleeding (including hematuria or hematochezia,) acute or chronicgastrointestinal illness, inflammatory bowel disease, or mucositis
5. Malignant disease / cancer requiring treatment in the past 3 years (except someprimary non melanoma skin cancer);
6. Severely impaired renal function defined as estimated glomerular filtration rate <30mL/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; Subjectsshould not have subacute or acute fevers of >101 degrees F at time of screening orrandomisation
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-prothrombintime or partial thromboplastin time at screening, or clinically significantabnormalities in other screening laboratories, including significant abnormalities invitamin B12 or thyroid function tests would be cause for exclusion.-
13. Abnormal liver function test results defined as aspartate aminotransferase (AST) >2.0x upper limit of normal (ULN); alanine aminotransferase (ALT) >2.0 x ULN; and / ortotal bilirubin >1.5 x ULN;
14. Known allergy or intolerance to AZD0530 or any excipients used in the investigationalmedicinal products.
15. Simultaneous participation in another interventional clinical study or anon-interventional study with imaging measures or invasive procedures (eg. collectionof blood or tissue samples); Participation in the FOP Connection Registry (www.fopconnection.org) or other studies in which patients completed studyquestionnaires are possible.
16. Treatment with another investigational or drug that might interfere with HO formationand the interpretation of the study drug in the last 90 days
17. Current use or history of regular alcohol consumption exceeding 14 units/week (6glasses 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.