HealthyPhase 1NCT00938678
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating Pegfilgrastim Hospira Compared to Neulasta (Amgen) in Healthy Volunteers
A Phase 1 study testing Pegfilgrastim Hospira and Neulasta (Amgen) in people with Healthy, run by Hospira, now a wholly owned subsidiary of Pfizer at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pegfilgrastim Hospira and Neulasta (Amgen)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2009to Oct 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Pegfilgrastim Hospira, Neulasta (Amgen)
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegfilgrastim HospiraDrug
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
Neulasta (Amgen)Drug
Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Experimental | Not described Receives: Drug: Pegfilgrastim Hospira |
| Treatment Group 2 | Active comparator | Not described Receives: Drug: Neulasta (Amgen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time 0 extrapolated to infinity (AUC0-∞) for serum Pegfilgrastim (PEG-GCSF)
Measured: 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.
Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
AUC0-t will be used as a primary parameter only if AUC0-∞ cannot be calculated for all subjects in the pharmacokinetic population.
Measured: 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
Measured: 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)
Secondary outcomes (8)
Maximum concentration (Cmax) for serum Pegfilgrastim (PEG-GCSF)
Measured: 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 to maximum concentration (Tmax) for serum Pegfilgrastim (PEG-GCSF)
Measured: 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 (λz) for serum Pegfilgrastim (PEG-GCSF)
Measured: 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.
Half-life (T½) for serum Pegfilgrastim (PEG-GCSF)
Measured: 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.
Area under the curve above baseline of ANC [ANC_AUC(0-tlast)]
Measured: 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)
Measured: 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)
Maximum change from baseline in CD34+ count (CD34+_Cmax)
Measured: 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 of maximum change from baseline for CD34+ count in days (CD34+_Tmax)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938678
- Sponsor's protocol ID
- PEG-09-01
- Other IDs
- EudraCT Number 2009-101433-42
- Status last verified
- Jun 2015
- First submitted
- 10 Jul 2009
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00938678
- Acronym / sponsor ID
- PEG-09-01
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Experimental | Drug: Pegfilgrastim Hospira |
| Treatment Group 2 | Active comparator | Drug: Neulasta (Amgen) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegfilgrastim HospiraSubjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events. | Drug | Treatment Group 1 |
| Neulasta (Amgen)Subjects in both treatment groups will have safety assessments and will be followed for all adverse and serious adverse events. | Drug | Treatment Group 2 |
Primary outcome
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.
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.
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)
8 secondary outcomes
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.
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.
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.
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.
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegfilgrastim Hospira and Neulasta (Amgen) in people with Healthy, run by Hospira, now a wholly owned subsidiary of Pfizer at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017; AzTrials last refreshed its copy on 6 Nov 2026.