Study With Heparin Sodium in Subcutaneous Administration

Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants

The purpose of this phase I study is to know the pharmacodynamic profile in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.

Study Overview

• Status: Suspended
• Conditions: Heparin
• Intervention / Treatment: Biological: Sodium Heparin UQ subcutaneous drug administration; Biological: Sodium Heparin FK subcutaneous drug administration

Detailed Description

This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide.

Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • União Química Farmacêutica Nacional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Eligible healthy participants should sign the Informed Consent Form,
• be between 18 and 60 years of age,
• be male,
• present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
• be characterized as a voluntary (Normal physical examination)
• no history of current or recent diseases.

Exclusion criteria:

• hemoglobin <12 g / dL;
• Platelets <100 x 109 / L;
• Regular or last 30 days use of anticoagulant medications;
• Current or past use of anti-inflammatory or anti-platelet medications;
• History of gastrointestinal bleeding;
• History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
• Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
• serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
• Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
• Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
• donation of blood (> 500 mL) in the preceding 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Sodium Heparin UQ First; The participants will receive the Sodium heparin UQ subcutaneous drug administration at first period and the Sodium heparin FK subcutaneous drug administration at second period	Biological: Sodium Heparin UQ subcutaneous drug administration; The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas; Biological: Sodium Heparin FK subcutaneous drug administration; The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
Experimental: Group Sodium Heparin FK First; The participants will receive the Sodium heparin FK subcutaneous drug administration at first period and the Sodium heparin UQ subcutaneous drug administration at second period	Biological: Sodium Heparin UQ subcutaneous drug administration; The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas; Biological: Sodium Heparin FK subcutaneous drug administration; The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of the anti-Xa factor	Chromogenic determination of direct and indirect inhibitors in human citrated plasma	8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of anti-IIa factor	Chromogenic determination of direct and indirect inhibitors in human citrated plasma	8 hours
activity of anti-Xa / anti-IIa ratio	the calculated ratio of the activity of anti-Xa / anti-IIa	8 hours
activity of tissue factor pathway activity (TFPI)	the Elisa assay will determine the activity of tissue factor pathway activity (TFPI)	8 hours
adverse events	Adverse events occurred in the study	45 days

Collaborators and Investigators

• Sponsor: União Química Farmacêutica Nacional S/A
• Collaborators: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
• Investigators: Study Director: Paula F Santos, União Química Farmacêutica Nacional S/A

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2022
• Primary Completion (Anticipated): April 20, 2023
• Study Completion (Anticipated): October 10, 2023

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Sodium Heparin; Coagulation factor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: PGUQ003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes