PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant Epoetin and Eprex, in Healthy Subjects

This study is not yet open for participant recruitment.
Verified September 2012 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Sponsor:
Information provided by (Responsible Party):
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT01685359
First received: July 26, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

The hypothesis of this trial is that the test drug (Human Recombiant Epoetin - Blau) pharmacokinetics and pharmacodynamics parameters are similar to the comparator drug (Eprex ® - Janssen-Cilag) in healthy subjects following administration of multiple intravenous dose. The objective of this randomized, parallel, clinical trial is to evaluate the pharmacokinetic and pharmacodynamic profile of the test drug Human Reconbiant Epoetin produced by Blau Farmacêutica, compared to the comparator drug Eprex®, produced by Janssen-Cilag, by assessing plasma concentration of the drug and the reticulocyte count following a multiple intravenous administration during 4 weeks of 100 IU/kg in healthy subjects.


Condition Intervention Phase
Healthy
Drug: Epoetin Alfa
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Assessment of Pharmacokinetics and Pharmacodynamics of Two Epoetin Alfa, Human Recombinant Epoetin (Blau Farmacêutica) and Eprex (Janssen-Cilag), After Multiple Dose, Intravenous Administration in Healthy Subjects: a Randomized Parallel Study.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • rHuEPO Serum Concentration [ Time Frame: 1, 8, 15, 19, 22 and 26 days after first administration ] [ Designated as safety issue: Yes ]

    Time frame on days 1, 8, 19 and 22: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h and 12h after administration;

    Time frame on day 26: -10min, 0h, 5min, 15min, 30min, 45min, 1,5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 36h after last drug administration.


  • Plasma reticulocyte count [ Time Frame: 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 29 days after first administration of the drug. ] [ Designated as safety issue: Yes ]

    Time frame on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26: 10 minutes before drug administration.

    Time frameon day 29: 72h +/- 2h after last drug administration.



Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Drug
Test Drug (Human Recombinant Epoetin alfa - Blau) dosage: 100 IU/kg intravenous administration
Drug: Epoetin Alfa
Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
Other Name: Eprex
Active Comparator: Eprex
Eprex (Janssen-Cilag, Epoetin alfa) dosage: 100 IU/kg intravenous administration
Drug: Epoetin Alfa
Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
Other Name: Eprex

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Agree to all the purposes of the study by signing and dating the Informed Consent;
  • Male, aged between 20 and 55 years, clinically healthy;
  • BMI between 18.5 and 30;
  • Hemoglobin between 13.8 and 15.4 g / dL and hematocrit between 41% and 49%;
  • VCM between 82 and 98, HBMC between 26 and 34, platelets between 150,000 and 400,000 units per mL. and WBC between 3,500 to 10,500 units per ml and no atypical cells.
  • Human serum ferritin between 36-262 mcg / L;
  • Counting of reticulocytes in peripheral blood ≤ 3%;
  • Serum erythropoietin < 30 mIU / mL.

Exclusion Criteria:

  • Participation in clinical trials in the 12 months preceding the survey;
  • Body weight > 100 kg;
  • Presence of iron deficiency anemia;
  • Presence of pulmonary, cardiovascular, neurological, endocrine, gastrointestinal, genitourinary or other systems diseases;
  • Acute disease in the period of 07 days before the beginning of the practical phase (administration of the drug) of the study;
  • Chronic administration of medications for hypertension, diabetes or any other disease that requires continuous use of any drug;
  • Hormone therapy in the period of 02 months preceding the beginning of the practical phase (administration of the drug) of the study;
  • Administration of any drug in the 02 weeks prior to the start of the practical period of the study;
  • Clinical history of autoimmune or hereditary anemia;
  • Clinical history of chronic bleeding;
  • Clinical history of acute bleeding in the 30 days preceding the beginning of practical phase of the study (administration of the drug);
  • Clinical history of allergy of biological products derived from mammalian albumin or any component of the formulation;
  • Current or previous history (less than 12 months) of illicit drug abuse and / or tobacco and / or alcohol or having consumed alcohol within 48 hours prior to the practical study periods (administration of the drug);
  • Prior therapies with erythropoietin;
  • Albumin below 3.5 g/dL or higher than 4.8 g/dL;
  • Signs or clinical history of bone marrow aplasia;
  • History and clinical or laboratory liver disease;
  • History and clinical or laboratory nephropathy;
  • Principal Investigator of the study criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685359

Contacts
Contact: Alexandre Frederico +55 19 38716399 alexandre@lalclinica.com.br

Locations
Brazil
LAL Clinica Not yet recruiting
Valinhos, Sao Paulo, Brazil, 13276-245
Contact: Bruna Franco    +55 19 38716399    bruna.franco@lalclinica.com.br   
Contact: Nathalia Ribeiro    +55 19 38716399    nathalia.ribeiro@lalclinica.com.br   
Principal Investigator: Alexandre Frederico         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier: NCT01685359     History of Changes
Other Study ID Numbers: EPOBLA0612IV-I2, Version 1 25/06/2012
Study First Received: July 26, 2012
Last Updated: September 11, 2012
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014