Status:
COMPLETED
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
Lead Sponsor:
Merckle GmbH
Conditions:
Pharmacokinetics
Pharmacodynamics
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participant...
Detailed Description
Eligible participants will be admitted to the investigational center and after confirming their eligibility will be randomized to receive a single dose of 30, 60, or 100 μg/kg lipegfilgrastim. There w...
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≥18.0 and ≤25 kg/m2.
- Body weight must be ≥ 50 kg and ≤ 90 kg.
- Is in good general health as determined by medical history, physical examination, 12-lead electrocardiography (ECG), vital signs and clinical laboratory tests.
- Subjects are able to read, write and understand English or Japanese; they must be able to understand the requirements of the study and be willing to comply with all trial requirements.
- Female subjects of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) test at screening and negative urine pregnancy test at check-in. All subjects must be either surgically sterile (for females that means documented complete hysterectomy, bilateral oophorectomyor bi-tubal ligations; partial hysterectomy is not sufficient), abstinent throughout the study or, if of reproductive capacity and not abstinent, exercising any 2 different forms of highly effective contraception methods with his/her partner during the entire study period.
- o Additional inclusion criteria for Japanese subjects:
- Subject must be a non-naturalized Japanese citizen and hold a Japanese passport.
- Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non-naturalized Japanese citizens, as confirmed by interview.
- Subject has been living outside of Japan for 10 years or fewer as confirmed by interview.
- o Additional inclusion criterion for Caucasian subjects:
- The subject is Caucasian, and confirms by interview that his/her parents and grandparents are Caucasian and none are of Black/African descent, Middle-Eastern descent or Asian descent.
- -other criteria apply, please contact the investigator for more information
Exclusion
- History of hypersensitivity to pegfilgrastim, filgrastim, lenograstim, Escherichia coli derived proteins, or to any excipients (glacial acetic acid, sodium hydroxide, sorbitol, polysorbate 20).
- Prior exposure to filgrastim, pegfilgrastim or lenograstim or other granulocyte colony stimulating factors (G-CSFs) in clinical development less than 6 months before randomization.
- Findings of splenomegaly on sonography, defined by splenic length in excess of 12.3 cm (Andrews, 2000; Benter et al, 2011) and clinical judgment.
- Existence or recent history of persistent pulmonary infiltrates or recent pneumonia, or current symptoms of upper respiratory infection. In the case of pneumonia, subject may be screened 12 weeks following cessation of antibiotic treatment.
- -other criteria apply, please contact the investigator for more information
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02306915
Start Date
October 1 2014
End Date
May 1 2015
Last Update
November 9 2021
Active Locations (1)
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1
Teva Investigational Site 34193
London, United Kingdom