To evaluate safety,kinetics & dynamics of PRT062607

• Research type

  Research Study

• Full title

  Single ascending dose, first in human study to assess the safety, pharmacokinetics and pharmacodynamics of a novel SYK inhibitor PRT062607 in healthy male and female subjects.

• IRAS ID

  44175

• Contact name

  Tim Mant

• Sponsor organisation

  Portola Pharmaceuticals

• Eudract number

  2009-018202-22

• Research summary

  In this study we are investigating how the body handles, breaks down and eliminates a new drug, PRT062607, how safe and well tolerated the drug is when given to healthy subjects as well as the effects this drug has on certain body immune cells. PRT062607 may be useful in disorders like rheumatoid arthritis. Rheumatoid arthritis is a chronic disabling and painful condition with an excess of immune reactions that attack mainly the joints and various other organs like skin, kidneys, lungs, heart and blood vessels. This is the first time this drug is given to human subjects. 48 healthy subjects divided into 7 sequential groups will be enrolled in the study. Each subject will take an oral dose of PRT062607 or placebo on one occasion. The study includes testing for the genes which are responsible for an enzyme (CYP2D6) which is involved in the metabolism (breakdown) of certain drugs which occurs predominantly in the liver. Enzymes are proteins that increase the rate of chemical reactions. The genes affect how efficient the enzyme is at breaking down these drugs. It is possible CYP2D6 is involved in the breakdown of the drug being investigated. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. It will involve 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 5 nights and 6 days. The follow up will be performed 14-21 days after dosing.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/4

• Date of REC Opinion

  1 Feb 2010

• REC opinion

  Favourable Opinion