Phase 1, single dose, PK + PD of Pegfilgrastim Hospira and Neulasta

• Research type

  Research Study

• Full title

  A phase 1, randomised, single dose, crossover study evaluating the pharmacokinetics and pharmacodynamics of Pegfilgrastim Hospira compared to Neulasta (Amgen) following subcutaneous administration to healthy volunteers

• IRAS ID

  22079

• Eudract number

  2009-010433-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Pegfilgrastim Hospira is a new version of Neulasta© and is being developed because the patent on Neulasta© is coming to an end. This means that companies are free to develop and sell copies of the drug. The study will compare the effects of Pegfilgrastim Hospira with Neulasta© on the body. The study will compare the concentrations of the drugs in the blood, how the body clears both drugs from the system and the effect of both drugs on the number of white blood cells (WBC). Safety and tolerability of both drugs will also be addressed. The drug will be used for chemotherapy patients who are at risk of infection due to low WBC count. Seventy, healthy, male and female subjects, 18 - 55y will be recruited. Subjects will attend a screening visit followed by 2 treatment periods which will each consist of a 5 night residential period followed by 8 out-patient visits. Subjects will receive a 6mg injection under the skin of one of the study drugs at the start of each treatment visit. The other drug will be given at the next treatment period. There will be approximately 20 days between each dosing. Vital signs (pulse, blood pressure and temperature), ECGs, physical examinations and blood and urine tests will be carried out at intervals throughout both treatment periods.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/9

• Date of REC Opinion

  8 Jun 2009

• REC opinion

  Favourable Opinion