HealthyPhase 1NCT01074593

Pharmacokinetics and Pharmacodynamics of the Interferon Beta-1a Produced by Laboratorio Quimico Farmaceutico Bergamo Compared to Interferon Beta-1a (Rebif - Merck Serono) in Healthy Subjects

A Phase 1 study testing Interferon beta-1a in people with Healthy, 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 objective of this study is to compare the pharmacokinetic and pharmacodynamic effect of two commercial preparations of interferon beta-1a (IFN Test: Lab Bergamo and IFN Comparator: Rebif ® - Merck Serono Lab) after single administration (12.000UI) in healthy subjects by modifying the parameters Cmax, Tmax… Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Interferon beta-1a
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteBrazil
Study dates: Jan 2011to Jul 2011
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Accepted Informed Consent
Study subjects male, aged 18 to 50 years;
Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.

Who cannot join

Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
Have been hospitalized for any reason, up to 8 weeks before the start of the study;
Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;
Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
To present the pressure of any etiology requiring pharmacological treatment;
Display history of myocardial infarction, angina and / or heart failure.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000

Other trials in Brazil

About this study

Official title: Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a (Rebif - Merck Serono) In Healthy Subjects

Read the detailed description

Secondly, safety will be observed (tolerability) clinically after administration of a single dose in study subjects, by comparing the clinical and laboratory parameters before and after study and the incidence of adverse events.

Conditions: Healthy
Being tested: Interferon beta-1a
Keywords: PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A

What participants receive

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

Interferon beta-1aBiological
12.000UI - single dose
Interferon beta-1aBiological
12.000UI - Single dose

Study groups in NCT01074593
Study group	Role	What they receive
Test	Experimental	Bergamo - Interferon beta-1a Receives: Biological: Interferon beta-1a
Comparator - Merck Serono	Active comparator	Merck Serono - Interferon beta-1a Receives: Biological: Interferon beta-1a

What is being measured

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

Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification
Measured: 168 hours

Secondary outcomes (1)

Security: observation of adverse effects
Measured: 168 hours

Timeline

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

Jan 2011Jul 2011

First posted24 Feb 2010 (estimated)
Study startJan 2011
Primary completionMar 2011
Study completionJul 2011

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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01074593
Sponsor's protocol ID: INTBER0609
Other IDs: VERSION 3
Status last verified: Feb 2013
First submitted: 13 Nov 2009
Last updated: 25 Feb 2013
Results posted: No
Data monitoring committee: 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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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of Pharmacokinetics and Pharmacodynamics of the Drug Interferon Beta-1a Produced By Laboratorio Quimico Farmaceutico Bergamo Compared To Interferon Beta-1a (Rebif - Merck Serono) In Healthy Subjects
ClinicalTrials.gov ID: NCT01074593
Acronym / sponsor ID: INTBER0609
Conditions: Healthy
Keywords: PHARMACOKINETICS AND PHARMACODYNAMICS OF DRUG INTERFERON BETA-1A
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Azidus BrasilIndustry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Mar 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 24 Feb 2010 (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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test	Experimental	Biological: Interferon beta-1aBergamo - Interferon beta-1a
Comparator - Merck Serono	Active comparator	Biological: Interferon beta-1aMerck Serono - Interferon beta-1a

Who may qualify

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

Key inclusion criteria (4 listed)

Accepted Informed Consent
Study subjects male, aged 18 to 50 years;
Research subjects with body mass index greater than or equal to 19 and less than or equal to 30;
Subjects considered healthy, based on the analysis of the clinical history and clinical and laboratory data.

Key exclusion criteria (8 listed)

Having donated or lost 450 mL or more of blood in the 6 months preceding the study;
Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study;
Having made regular use of medication in the 4 weeks prior to the start of the study or have made use of medications that interfere with the pharmacokinetics / pharmacodynamics of drugs studied a week before the start of the study;
Have been hospitalized for any reason, up to 8 weeks before the start of the study;
Demonstrate a history of alcohol abuse, drugs, or drugs, or have consumed alcohol within 48 hours prior to the period of hospitalization;

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
Interferon beta-1a12.000UI - single dose	Biological	Test
Interferon beta-1a12.000UI - Single dose	Biological	Comparator - Merck Serono

Primary outcome

Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a.
Time frame: 168 hours
Assessment of pharmacodynamics: cholinesterase activity 2'5' oligoadenylate synthase and beta-2-microglobulin.Pharmacokinetics measured through plasma quantification

1 secondary outcome

Security: observation of adverse effects
Time frame: 168 hours

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 25 Feb 2013.

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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 Interferon beta-1a in people with Healthy, 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 4 inclusion and 8 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 25 Feb 2013. 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?

Comparison of pharmacokinetic and pharmacodynamic effect between two commercial preparations of interferon beta-1a. (time frame: 168 hours). 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 NCT01074593.

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 25 Feb 2013.