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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

July 10, 2009
June 17, 2015
June 2009
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Pharmacokinetics: AUC(0-t) [ Time Frame: 46 days ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Maximum change from baseline in ANC; ANC_Cmax [ Time Frame: 46 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00938678 on ClinicalTrials.gov Archive Site
  • 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 ]
Cmax, Tmax, half-life [ Time Frame: 46 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Pegfilgrastim Hospira
    Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
  • Drug: Neulasta (Amgen)
    Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
  • Experimental: Treatment Group 1
    Intervention: Drug: Pegfilgrastim Hospira
  • Active Comparator: Treatment Group 2
    Intervention: Drug: Neulasta (Amgen)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00938678
PEG-09-01, EudraCT Number 2009-101433-42
No
Not Provided
Not Provided
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP