Pharmacokinetics and Pharmacodynamics of Interferon Alpha 2A (interferon)

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01228422
First received: October 21, 2008
Last updated: October 25, 2010
Last verified: March 2009
  Purpose

The aim was to verify the Pharmacokinetics and Pharmacodynamics of alpha interferon product-2A - Blausiegel, taking as the comparator drug product Roferon ® A (interferon alpha-2A - Roche Laboratory).


Condition Intervention
Healthy
Biological: Interferon alpha 2a

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Study of Pharmacokinetics and Pharmacodynamics of Alpha Interferon-2A of Blausiegel Trade and Industry the Compared the Product Roferon A, of Laboratory of Roche

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Evaluate in parallel pharmacodynamic parameters and pharmacokinetics. [ Time Frame: 96 hours. ] [ Designated as safety issue: No ]
    Pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.


Secondary Outcome Measures:
  • Evaluation of clinical safety through a comparison of clinical and laboratory parameters pre-and post-study and the incidence of adverse events [ Time Frame: 96 hours. ] [ Designated as safety issue: Yes ]
    The pharmacokinetic parameters of the drug will be held 17 blood samples over a period of 96 hours. The parameters Cmax, Tmax, area under the curve (AUC), among others, will be quantified in each individual. The pharmacodynamics will be studied from the alteration of endogenous biomarkers sensitive to stimulation by interferon.


Estimated Enrollment: 24
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
test interferon - blausiegel
Biological: Interferon alpha 2a
3MUI
2
reference interferon - Roferon A (Roche)
Biological: Interferon alpha 2a
3MUI

Detailed Description:

The Interferons (IFNs) are a group of cytokines produced by vertebrates in response to various stimuli, including the presence of foreign nucleic acids in the body, bacteria, tumor cells and viral antigens. These proteins have significant shares immunomodulatory, antiproliferative and antiviral drugs, the first line of defense of the body. Once produced, the IFNs block viral replication, maximize the lytic activity of natural killer cells, increase the expression of MHC class I in cells infected by viruses and induce the development of Th1 cells The production of interferon alpha-2A is now held by biotechnology with the establishment of a chain of DNA producer of interferon alpha-2a in the chain of original DNA of a bacterium, allowing the bacteria produce this drug on an industrial scale. In the process of synthesis, the 165 amino acids that are part of this molecule can change in your order with no reduction in activity or changes in the properties.

Due to this fact, the biological and medicinal considered, especially those in manufacturing by genetic engineering, need to prove their clinical activity so that they can be marketed. In the case of interferon, the consequences of the use of a product without activity compared to treat patients with Hepatitis C can lead to serious health complications from them. It is therefore necessary to prove its clinical activity and pharmacokinetics before its clinical efficacy. The sponsor of this study aims to end the renewal of registration of interferon alpha-2A with the Ministry of Health So this study to evaluate the Pharmacokinetics and Pharmacodynamics of interferon alpha-2a may allow in the future this medicine can be used by a year in patients with hepatitis C, without risk to their health, besides those already known and inherent in the treatment of any interferon.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy volunteers

Criteria

Inclusion Criteria:

  • Accepting the End of Free and Informed Consent;
  • Research subjects were male, aged 18 to 55 years;
  • Research subjects with body mass index ≥ 19 and ≤ 30;
  • Be considered healthy, from the analysis of medical history, medical examination and laboratory tests within the normal range.

Exclusion Criteria:

  • Results of laboratory tests outside the values considered acceptable in accordance with the criteria of medical evaluator;
  • Having participated in any experimental study or have ingested any experimental drug in the last three months before the start of the study;
  • Have made regular use of medication in the past 4 weeks preceding the start of the study or have made use of any medication a week before the start of the study;
  • Have been hospitalized for any reason, up to 8 weeks before the start of the study;
  • Present history of abuse of alcohol, drugs or medications, or have ingested alcohol within 48 hours prior to the period of stay;
  • Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological or psychiatric;
  • Present pressure changes of any cause that requires pharmacological treatment; present history of myocardial infarction, angina and / or heart failure;
  • Have donated or lost 450 ml of blood or more in the three months preceding the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228422

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
Principal Investigator: Alexandre Frederico, Doctor L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT01228422     History of Changes
Other Study ID Numbers: INT2ABLA0908
Study First Received: October 21, 2008
Last Updated: October 25, 2010
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Will be studied 24 subjects divided Research and 2 parallel groups
The treatment is a dose of 3MUI of alpha interferon 2nd
There will be collection of blood at times: 0, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours.
The volunteers will be hospitalized 24 hours.
Will be measured labels the AUC, Tmax, Cmax, neopterin and beta2-microglobulin

Additional relevant MeSH terms:
Interferons
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014