Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations

NCT02589301 | Completed Phase 1

• 1 other identifier: EF143
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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%.

  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%.

  16 days

• Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with parameters: absolute neutrophil count (ANC) versus time.

  16 days

Secondary Outcomes (1)

• Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with CD34+ count versus time.

  6 days

Study Arms (2)

Pegfilgrastim

EXPERIMENTAL

Pegfilgrastim (Hematopoietic Growth Factor) injectable solution 6 mg / 0,6mL in a single subcutaneous application.

Biological: Pegfilgrastim

Neulastim (pegfilgrastim)

ACTIVE COMPARATOR

Neulastim injectable solution 6 mg / 0,6mL in a single subcutaneous application.

Biological: Pegfilgrastim

Interventions

Pegfilgrastim BIOLOGICAL

Neulastim (pegfilgrastim); Pegfilgrastim

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Unidade Integrada de Farmacologia e Gastroenterologia

Bragança Paulista, São Paulo, Brazil

Location

MeSH Terms

Conditions

Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• José Pedrazzoli Junior

  Unidade Integrada de Farmacologia e Gastroenterologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 7, 2017

Record last verified: 2016-11

Locations

BR (1)