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Neulasta

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 20, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00938678Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy VolunteersPHASE1 COMPLETED 71 — — Jun 1, 2009Oct 1, 2009Mar 20, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Area under the curve from time 0 extrapolated to infinity (AUC0-∞) for serum Pegfilgrastim (PEG-GCSF)
Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.

AUC0-t will be used as a primary parameter only if AUC0-∞ cannot be calculated for all subjects in the pharmacokinetic population.

Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax
Screening, Day -1, Treatment Periods 1 & 2: Pre-dose (-60 min, -30 min, 0 min), Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2)
Secondary Endpoints
Maximum concentration (Cmax) for serum Pegfilgrastim (PEG-GCSF)
Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
Time to maximum concentration (Tmax) for serum Pegfilgrastim (PEG-GCSF)
Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
Terminal elimination rate constant (λz) for serum Pegfilgrastim (PEG-GCSF)
Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment Group 1EXPERIMENTAL -
Treatment Group 2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Pegfilgrastim HospiraDRUGSubjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
Neulasta (Amgen)DRUGSubjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female subjects, 18-55 years inclusive. * Written informed consent given * Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study. * Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive and wei...

Countries:United Kingdom
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