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Neulasta

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

Neulasta · 1 trial · 1 indication

Phase 1 1
NCT00938678Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy VolunteersHealthy
COMPLETED71 Analytics
PHASE1COMPLETED
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
Healthy
NCT0093867871
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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 to 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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Frequently asked questions about Neulasta

What is Neulasta used for?

Neulasta is a drug being studied in healthy volunteers. It is currently in Phase 1 clinical development. The drug is being evaluated for use in healthy individuals, though it is not yet approved for any specific indication.

Who makes Neulasta?

Neulasta is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in healthy volunteers.

What phase is Neulasta in?

Neulasta is currently in Phase 1 clinical development. It has completed one Phase 1 trial, which was an active-controlled study in healthy volunteers. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is Neulasta in?

Neulasta has been studied in one clinical trial, NCT00938678. This was a Phase 1 pharmacokinetic/pharmacodynamic study comparing pegfilgrastim Hospira to Neulasta (Amgen) in healthy volunteers. The trial was completed and enrolled 71 participants in the United Kingdom.

Is Neulasta the same as pegfilgrastim Hospira?

Neulasta is being compared to pegfilgrastim Hospira in a clinical trial. The trial was designed to evaluate the pharmacokinetics and pharmacodynamics of pegfilgrastim Hospira compared to Neulasta (Amgen) in healthy volunteers. The study was active-controlled, meaning Neulasta served as the active comparator.