- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02306915
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
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
Study Overview
Status
Conditions
Intervention / Treatment
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 will be 11 visits to the investigational center during the study, including a screening visit, 1 inpatient period (through Day 4 post-dose) and 9 ambulatory visits.
Blood samples for PK, PD and immunogenicity analysis will be collected pre-dose and at specified time points post-dose. A mandatory blood sample for pharmacogenetics (PGx) will be collected from all participants. During the study the following safety assessments will be performed: vital signs measurements,physical examinations, record of adverse events, clinical laboratory tests, urinalysis, safety ECG recordings, local tolerability (injection site reactions), overall tolerability, pregnancy testing, spleen sonography, and concomitant medications
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom
- Teva Investigational Site 34193
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lipegfilgrastim 30
|
lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg
|
Experimental: lipegfilgrastim 60
|
lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg
|
Experimental: lipegfilgrastim 100
|
lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK: Area under the serum concentration-time curve (AUC), from time 0 to the last measurable concentration (AUC0-t)
Time Frame: Days 1-8, 10, 14, 17, 21
|
2 hours for visits 3, 9; 1 day for visit 10
|
Days 1-8, 10, 14, 17, 21
|
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Maximum observed serum drug concentration (Cmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Time to maximum observed serum drug concentration (tmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
The percentage of the extrapolated area to infinity in relation to the total area under the curve (%AUCext)
Time Frame: Visits 3, 9, 10
|
Visits 3, 9, 10
|
|
Apparent serum terminal elimination rate constant (λz)
Time Frame: Days 1-8, 10, 14, 17, 21
|
2 hours for visits 3, 9; 1 day for visit 10
|
Days 1-8, 10, 14, 17, 21
|
Associated elimination half-life (t½)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Mean residence time (MRT)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Apparent total body clearance (CL/F)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Apparent volume of distribution during the terminal phase (Vz/F)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
PD: ANC area over baseline effect curve (ANC AOBEC)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Maximum measured ANC value after dosing (ANC Cmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Time point at which ANC Cmax is observed (ANC tmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Time (days) until ANC returns to baseline value
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
CD34+ area over the baseline effect curve (CD34+ AOBEC)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Maximum measured CD34+ value after dosing (CD34+ Cmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
|
Time point at which CD34+ Cmax is observed (CD34+ tmax)
Time Frame: Days 1-8, 10, 14, 17, 21
|
Days 1-8, 10, 14, 17, 21
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants with Adverse Events
Time Frame: 28 Days
|
28 Days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- XM22-PK-10036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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