STUDY TO EVALUATE THE INTERACTION BETWEEN KETOCONAZOLE AND BMS-754807

• Research type

  Research Study

• Full title

  AN OPEN-LABEL, SINGLE-SEQUENCE STUDY OF THE EFFECTS OF KETOCONAZOLE ON THE PHARMACOKINETICS OF BMS-754807 IN HEALTHY SUBJECTS

• IRAS ID

  92978

• Contact name

  Simon Singer

• Sponsor organisation

  Bristol-Myers Squibb Co.

• Eudract number

  2011-004848-22

• ISRCTN Number

  1

• Research summary

  The drug being tested in this study, BMS-754807, blocks the activities of two cell surface receptors, the insulin-like growth factor 1 receptor (IGF-1R) and the insulin receptor (IR). A cell surface receptor is a structure that sits in the cell membrane, i.e. the outer lining of the cell, and on activation by binding molecules like hormones, initiates specific activity within the cell. Both receptors, IGF-1R and IR play important roles in the proliferation of cells, thereby leading to the development and growth of certain cancers. These two receptors, the IGF-1R and IR, also have vital parts in the normal growth and functions of the human body, the insulin receptor being the means by which blood glucose (sugar) levels are controlled. The deactivation of both receptors by BMS-754807 is a promising new addition to the armoury of cancer treatments. BMS-754807 has been administered in single and multiple doses to both healthy volunteers and cancer patients without any major safety issues. Ketoconazole is a drug used to treat certain fungal infections and commonly employed in clinical trials to assess drug interactions; it has been on the market since 1981.

• REC name

  Wales REC 1

• REC reference

  11/WA/0349

• Date of REC Opinion

  19 Jan 2012

• REC opinion

  Further Information Favourable Opinion