NeutropeniaPhase 1NCT02589301
Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations
A Phase 1 study testing Pegfilgrastim in people with Neutropenia and Healthy, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
Trial summary
This study will evaluate the pharmacokinetics (relative bioavailability) and pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes, between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim® (reference formulation), marketed by Produtos Roche… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Neutropenia, Healthy
- What is being tested?
- Pegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Nov 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index equals to or higher than 18.5 and equals to or less than 29.9 kg/m2.
- The volunteer is in good health conditions and does not have clinically significant diseases, as per medical opinion, according to Medical History, measurements of Blood Pressure, Heart Rate and Temperature, Physical Exam, Electrocardiogram, and complementary Laboratorial Exams.
- Able to understand the study nature and objective, including risks and adverse events and who intends to cooperate with the researcher and act according to the whole study requirements, which is confirmed by the signature in the Informed Consent Form.
Who cannot join
- The volunteer is known to have hypersensitivity to the study drug product or to chemically-related compounds.
- History or presence of hepatic or gastrointestinal diseases or other condition interfering with drug product absorption, distribution, excretion or metabolism.
- Use of maintenance therapy with any drug product, except for oral contraceptive pills.
- History of hepatic, renal, pulmonary, gastrointestinal, neurological, hematological, psychiatric, cardiologic or allergic disease of any etiology requiring pharmacological treatment or that is considered clinically relevant by the researcher.
- Electrocardiographic findings are not recommended by the researcher for participating in the study.
- Results of complementary laboratorial exams outside the values considered normal according to this protocol rules, unless they are considered non-clinically significant by the researcher.
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- Smoking.
- Daily intake of more than 5 cups of tea or coffee.
- History of drug or alcohol abuse.
- Use of regular medication within 2 weeks preceding the beginning of this study or use of any medication one week before starting this study.
- Hospital admission for any reason up to 8 weeks before the start of the first study treatment period.
- Treatment in the last 3 months before starting this study treatment with any drug product known to have a well-defined toxic potential in large organs.
- Participation in any pharmacokinetics study with collection of more than 300 mL of blood or intake of any experimental drug product in the last six months before starting the study treatment.
- Donation or loss of 450 mL or more of blood in the last three months preceding the study or donation of more than 1500 mL of blood in the last 12 months before starting the study treatment.
- Reagent result for urine βHCG exam, performed in female volunteers.
- Positive result in urine test for detection of abuse drugs.
- Result higher than 0.1 mg/L in ethylometer test.
- Any condition preventing participation in the study as per researcher's opinion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Unidade Integrada de Farmacologia e Gastroenterologia
Bragança Paulista, São Paulo
About this study
Official title: A Single-center, Open-label, Parallel Study With Single Subcutaneous Injection for Pharmacokinetics and Pharmacodynamics Comparison of Two Pegfilgrastim Formulations in Both Male and Female Healthy Volunteers, Test Formulation is an Injectable Solution Containing 6 mg of Pegfilgrastim, Manufactured by Eurofarma Laboratórios S/A, and Reference Formulation (Neulastim® Injectable Solution Containing 6 mg) Marketed by Produtos Roche Químicos e Farmacêuticos S/A
This study will evaluate the pharmacokinetics (relative bioavailability) and pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes, between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim® (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.
In addition to that, a pharmacodynamics comparison will be performed, through change in absolute neutrophil count in leukogram performed in the same time of pharmacokinetics analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00, 96:00 and 384:00 hours.
- Conditions
- Neutropenia, Healthy
- Being tested
- Pegfilgrastim
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegfilgrastimBiological
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim | Experimental | Pegfilgrastim (Hematopoietic Growth Factor) injectable solution 6 mg / 0,6mL in a single subcutaneous application. Receives: Biological: Pegfilgrastim |
| Neulastim (pegfilgrastim) | Active comparator | Neulastim injectable solution 6 mg / 0,6mL in a single subcutaneous application. Receives: Biological: Pegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter peak maximum concentration in plasma (Cmax).
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for Cmax. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter:
(Cmax test / Cmax comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Measured: 16 days
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter area under recombinant G-CSF concentration curve versus time (AUC 0-t).
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for AUC 0-t. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter:
(AUC0-t test / AUC0-t comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Measured: 16 days
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with parameters: absolute neutrophil count (ANC) versus time.
Measured: 16 days
Secondary outcomes (1)
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with CD34+ count versus time.
CD34+ count until 144 hours
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Pedrazzoli Junior, Principal investigator, Unidade Integrada de Farmacologia e Gastroenterologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589301
- Sponsor's protocol ID
- EF143
- Status last verified
- Nov 2016
- First submitted
- 20 Oct 2015
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Parallel Study With Single Subcutaneous Injection for Pharmacokinetics and Pharmacodynamics Comparison of Two Pegfilgrastim Formulations in Both Male and Female Healthy Volunteers, Test Formulation is an Injectable Solution Containing 6 mg of Pegfilgrastim, Manufactured by Eurofarma Laboratórios S/A, and Reference Formulation (Neulastim® Injectable Solution Containing 6 mg) Marketed by Produtos Roche Químicos e Farmacêuticos S/A
- ClinicalTrials.gov ID
- NCT02589301
- Acronym / sponsor ID
- EF143
- Conditions
- Neutropenia, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Oct 2015 (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 will evaluate the pharmacokinetics (relative bioavailability) and pharmacodynamics, after single subcutaneous application, in healthy volunteers of both sexes, between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and Neulastim® (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.
In addition to that, a pharmacodynamics comparison will be performed, through change in absolute neutrophil count in leukogram performed in the same time of pharmacokinetics analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00, 96:00 and 384:00 hours.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim | Experimental | Biological: PegfilgrastimPegfilgrastim (Hematopoietic Growth Factor) injectable solution 6 mg / 0,6mL in a single subcutaneous application. |
| Neulastim (pegfilgrastim) | Active comparator | Biological: PegfilgrastimNeulastim injectable solution 6 mg / 0,6mL in a single subcutaneous application. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index equals to or higher than 18.5 and equals to or less than 29.9 kg/m2.
- The volunteer is in good health conditions and does not have clinically significant diseases, as per medical opinion, according to Medical History, measurements of Blood Pressure, Heart Rate and Temperature, Physical Exam, Electrocardiogram, and complementary Laboratorial Exams.
- Able to understand the study nature and objective, including risks and adverse events and who intends to cooperate with the researcher and act according to the whole study requirements, which is confirmed by the signature in the Informed Consent Form.
Key exclusion criteria (18 listed)
- The volunteer is known to have hypersensitivity to the study drug product or to chemically-related compounds.
- History or presence of hepatic or gastrointestinal diseases or other condition interfering with drug product absorption, distribution, excretion or metabolism.
- Use of maintenance therapy with any drug product, except for oral contraceptive pills.
- History of hepatic, renal, pulmonary, gastrointestinal, neurological, hematological, psychiatric, cardiologic or allergic disease of any etiology requiring pharmacological treatment or that is considered clinically relevant by the researcher.
- Electrocardiographic findings are not recommended by the researcher for participating in the study.
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 | Biological | Neulastim (pegfilgrastim), Pegfilgrastim |
Primary outcome
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter peak maximum concentration in plasma (Cmax).
Time frame: 16 days
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for Cmax. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter: (Cmax test / Cmax comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter area under recombinant G-CSF concentration curve versus time (AUC 0-t).
Time frame: 16 days
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for AUC 0-t. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter: (AUC0-t test / AUC0-t comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with parameters: absolute neutrophil count (ANC) versus time.
Time frame: 16 days
1 secondary outcome
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with CD34+ count versus time.
Time frame: 6 days
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 7 Feb 2017.
Related trials for Neutropenia
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Acquired Primary Autoimmune and Idiopathic Chronic Neutropenia Disorders, Chronic Neutropenia
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Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
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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.
José Pedrazzoli Junior principal investigator
Unidade Integrada de Farmacologia e Gastroenterologia
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 in people with Neutropenia and Healthy, run by Eurofarma Laboratorios S.A. at 1 site in Brazil.
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 3 inclusion and 18 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 7 Feb 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 Brazil. 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?
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter peak maximum concentration in plasma (Cmax). (time frame: 16 days). 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 7 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.