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

NCT ID: NCT00938678

Last Updated: 2017-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2009-10-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Group 1

Group Type: EXPERIMENTAL

Pegfilgrastim Hospira

Intervention Type: DRUG

Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

Treatment Group 2

Group Type: ACTIVE_COMPARATOR

Neulasta (Amgen)

Intervention Type: DRUG

Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

Interventions

Pegfilgrastim Hospira

Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

Intervention Type: DRUG

Neulasta (Amgen)

Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient Clinical Ltd

Edinburgh, , United Kingdom

Countries

United Kingdom

Other Identifiers

EudraCT Number 2009-101433-42

Identifier Type: -

Identifier Source: secondary_id

PEG-09-01

Identifier Type: -

Identifier Source: org_study_id