Healthy SubjectsPhase 1NCT01549301

Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.

A Phase 1 study testing Filgrastim in people with Healthy Subjects, run by Azidus Brasil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the… Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: Filgrastim
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 1 siteBrazil
Study dates: Aug 2012to Sep 2013
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

Agree with all study procedures, sign and date back by their own free will, the IC;
Be between 18 and 50 years, of both sexes;
Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
are considered healthy, clinical, psychological and laboratory;
are female, but they have and maintain a safe method of contraception during the study.

Who cannot join

Known hypersensitivity to filgrastim;
Hypersensitivity to products derived from E. coli;
fever or infectious disease in the 07 days preceding the first administration;
Positive serology for hepatitis B or C and HIV;
Prior treatment with CSFs, interleukins and interferons;
Participation in a clinical study in the last 12 months;

Show all 11Show fewer

Donation or loss of blood in the 03 months preceding the study;
General anesthesia in the 03 months preceding the study;
Provide a history of alcohol abuse, drug or drugs;
Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
Pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

LAL Clinica Pesquisa e Desenvolvimento Ltda
Valinhos, São Paulo

Other trials in Brazil

About this study

Conditions: Healthy Subjects
Being tested: Filgrastim

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FilgrastimDrug
filgrastim, single dose, s.c., dosage: 5 mcg/kg
FilgrastimDrug
filgrastim, single dose, s.c., dosage: 10 mcg/kg
FilgrastimDrug
Filgrastim, i.v., single dose, dosage: 5 mcg/kg
FilgrastimDrug
Filgrastim, i.v., single dose, dosage: 10 mcg/kg

Study groups in NCT01549301
Study group	Role	What they receive
Group D 10 i.v.	Experimental	Two periods, crossover, single dose, i.v., 10 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis. Receives: Drug: Filgrastim
Group C 5 i.v.	Experimental	Two periods, crossover, single dose, i.v., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis. Receives: Drug: Filgrastim
Group B 10 s.c.	Experimental	Two periods, crossover, single dose, s.c., 10 mcg/kg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis. Receives: Drug: Filgrastim
Group A 5 s.c.	Experimental	Two periods, crossover, single dose, s.c., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis. Receives: Drug: Filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
Measured: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Sep 2013

First posted9 Mar 2012 (estimated)
Study startAug 2012
Primary completionAug 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01549301
Sponsor's protocol ID: FILBLA1211I
Other IDs: Version 01 - 09/12/2011
Status last verified: Jan 2018
First submitted: 6 Mar 2012
Last updated: 20 Jun 2018
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
ClinicalTrials.gov ID: NCT01549301
Acronym / sponsor ID: FILBLA1211I
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Aug 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 9 Mar 2012 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group D 10 i.v.	Experimental	Drug: FilgrastimTwo periods, crossover, single dose, i.v., 10 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
Group C 5 i.v.	Experimental	Drug: FilgrastimTwo periods, crossover, single dose, i.v., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
Group B 10 s.c.	Experimental	Drug: FilgrastimTwo periods, crossover, single dose, s.c., 10 mcg/kg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
Group A 5 s.c.	Experimental	Drug: FilgrastimTwo periods, crossover, single dose, s.c., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Agree with all study procedures, sign and date back by their own free will, the IC;
Be between 18 and 50 years, of both sexes;
Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
are considered healthy, clinical, psychological and laboratory;
are female, but they have and maintain a safe method of contraception during the study.

Key exclusion criteria (11 listed)

Known hypersensitivity to filgrastim;
Hypersensitivity to products derived from E. coli;
fever or infectious disease in the 07 days preceding the first administration;
Positive serology for hepatitis B or C and HIV;
Prior treatment with CSFs, interleukins and interferons;

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
Filgrastimfilgrastim, single dose, s.c., dosage: 5 mcg/kg	Drug	Group A 5 s.c.
Filgrastimfilgrastim, single dose, s.c., dosage: 10 mcg/kg	Drug	Group B 10 s.c.
FilgrastimFilgrastim, i.v., single dose, dosage: 5 mcg/kg	Drug	Group C 5 i.v.
FilgrastimFilgrastim, i.v., single dose, dosage: 10 mcg/kg	Drug	Group D 10 i.v.

Primary outcome

The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
Time frame: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h

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 Jun 2018.

Related trials for Healthy Subjects

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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 Filgrastim in people with Healthy Subjects, run by Azidus Brasil 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 5 inclusion and 11 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 Jun 2018. 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?

The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug. (time frame: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01549301.

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 Jun 2018.