Comparing lipegfilgrastim in Japanese and Caucasian volunteers; ver 1
Research type
Research Study
Full title
A Randomized, Double-Blind Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Single Subcutaneous Administration of Lipegfilgrastim (Doses up to 100 µg/kg) in Healthy Japanese and Caucasian Subjects (HMR code: 14-018)
IRAS ID
163002
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Teva Pharma GmbH
Eudract number
2014-002529-36
Research summary
The study medicine is an existing medicine for treating neutropenia, sufferers of which have low numbers of neutrophils (a type of white blood cell). Neutropenia is usually caused by medicines that affect the immune system. People who have neutropenia are prone to infections, which often cause fever.
G-CSF is a protein found naturally in the body that helps the body produce neutrophils. The study medicine is a form of G-CSF, and works the same way. It is already used in Europe to treat neutropenia, but it would be a useful treatment for patients in other countries, including Japan.
We’re doing this study to find out whether the study medicine has similar blood levels, side effects and effects in healthy Japanese and Caucasian people. We’ll also test how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll give 24 Japanese and 24 Caucasian participants, aged 20-45 years, single doses of 0.03 mg/kg, 0.06 mg/kg or 0.1 mg/kg study medicine, by injection under the skin.
Participants will take up to 8 weeks to finish the study. They’ll stay on the ward for 4 nights and make 10 outpatient visits.
A pharmaceutical company (Merckle GmbH) is funding the study.
The study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
14/LO/1449
Date of REC Opinion
19 Sep 2014
REC opinion
Favourable Opinion