Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00938678
First received: July 10, 2009
Last updated: June 17, 2015
Last verified: June 2015
  Purpose

This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim Hospira and Neulasta® following a single dose of 6 mg of each product administered subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.


Condition Intervention Phase
Healthy
Drug: Pegfilgrastim Hospira
Drug: Neulasta (Amgen)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase I, Randomized, Single Dose, Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Pegfilgrastim Hospira Compared to Neulasta (Amgen) Following Subcutaneous Administration to Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Area under the curve from time 0 extrapolated to infinity (AUC0-∞) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum concentration (Cmax) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Time to maximum concentration (Tmax) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Terminal elimination rate constant (λz) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Half-life (T½) for serum Pegfilgrastim (PEG-GCSF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Area under the curve above baseline of ANC [ANC_AUC(0-tlast)] [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Time of maximum change from baseline for ANC in days (ANC_Tmax) [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Maximum change from baseline in CD34+ count (CD34+_Cmax) [ Time Frame: Day -1, Treatment Periods 1 & 2: Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2) ] [ Designated as safety issue: No ]
  • Time of maximum change from baseline for CD34+ count in days (CD34+_Tmax) [ Time Frame: Day -1, Treatment Periods 1 & 2: Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2) ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: June 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group 1 Drug: Pegfilgrastim Hospira
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
Active Comparator: Treatment Group 2 Drug: Neulasta (Amgen)
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 weight not <50 kg or >100 kg.
  • Female subjects who are using an effective method of contraception, or are surgically sterile.
  • Non-smokers or ex-smokers who have not smoked within the previous 12 months.

Exclusion Criteria:

  • Hypersensitivity to the Investigational medicinal product (IMP) or its constituents and/or hypersensitivity to E. Coli derived proteins, and/or previous exposure to the IMP.
  • History or presence of any clinically significant findings that, in the opinion of the Investigator, would preclude inclusion in the study.
  • History or presence of any clinically significant gastrointestinal pathology or symptoms, liver or kidney disease, or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
  • Any clinically significant laboratory findings, including any ANC, platelet or haemoglobin result outside the reference range of the local laboratory.
  • Abnormal vital signs or abnormal 12-lead electrocardiogram (ECG) results, as judged by the Investigator to be clinically significant.
  • Females, pregnant or lactating, or planning to become pregnant during the time the subject is on study.
  • Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months from the date of the screening visit.
  • Hereditary fructose intolerance.
  • Participation in any other clinical trial using a investigational product or device, within the previous 12 weeks from the date of the screening visit.
  • Positive result for human immunodeficiency virus (HIV) and/or hepatitis B and C tests.
  • Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit.
  • Blood donation >=500 mL in the previous 12 weeks from the date of the screening visit.
  • Use of any prescription medication (excluding hormonal contraceptives) within 14 days prior to date of the screening visit.
  • Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body). Vitamins, minerals and nutritional supplements may be taken at the discretion of the Investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938678

Locations
United Kingdom
Quotient Clinical Ltd
Edinburgh, United Kingdom, EH14 4AP
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00938678     History of Changes
Other Study ID Numbers: PEG-09-01, EudraCT Number 2009-101433-42
Study First Received: July 10, 2009
Last Updated: June 17, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Hospira, Inc.:
Healthy volunteers

ClinicalTrials.gov processed this record on July 01, 2015