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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00938678
• Date of registration: 10/07/2009
• Prospective Registration: No
• Primary sponsor: Hospira, now a wholly owned subsidiary of Pfizer
• Public title: Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
• Scientific 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
• Date of first enrolment: June 2009
• Target sample size: 71
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00938678
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Pegfilgrastim Hospira

Drug: Neulasta (Amgen)

Primary Outcome(s)

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.]

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)]

Area under the curve from time 0 extrapolated to infinity (AUC0-8) 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.]

Secondary Outcome(s)

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)]

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)]

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.]

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)]

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.]

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)]

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.]

Terminal elimination rate constant (?z) 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.]

Secondary ID(s)

EudraCT Number 2009-101433-42

PEG-09-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors