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Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
This study is currently recruiting participants.
Verified by Hospira, Inc., July 2009
First Received: July 10, 2009   No Changes Posted
Sponsored by: Hospira, Inc.
Information provided by: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT00938678
  Purpose

Compare pegylated granulocyte colony-stimulating factor (PEG-GCSF) pharmacokinetics (PK) and pharmacodynamics (PD) from Pegfilgrastim Hospira and Neulasta (R) following a single dose of 6 mg delivered by subcutaneous (SC) injection in healthy volunteers.


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

Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
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:
  • 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 ]

Secondary Outcome Measures:
  • Cmax, Tmax, half-life [ Time Frame: 46 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: July 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment Group 1: Experimental Drug: Pegfilgrastim Hospira
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
Treatment Group 2: Active Comparator 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 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 study drug or its constituents and/or hypersensitivity to E. Coli derived proteins, and/or previous exposure to the study drug.
  • 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938678

Contacts
Contact: Stuart Mair, MBChB, DRCOG, DCPSA +44 (0) 1875 618 149 stuart.mair@eur.crl.com

Locations
United Kingdom, Lothian
Quotient Clinical Ltd Recruiting
Edinburgh, Lothian, United Kingdom, EH14 4AP
Principal Investigator: Stuart Mair, MBChB DRCOG DCPSA            
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

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

Keywords provided by Hospira, Inc.:
Healthy volunteers

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on September 11, 2009