To Investigate the Pharmacokinetics of EPORON® and EPREX® After Subcutaneous Administration in Healthy Male Volunteers

NCT02580006 | Unknown Phase 1 DMC

• 1 other identifier: DA3285_SC_I
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I study is to compare pharmacokinetics, safety and pharmacodynamics of EPORON and EPREX after single subcutaneous administration.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Area Under Curve last(AUClast) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Maximum of concentration(Cmax) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Reticulocyte count (%) compared to baseline

  The absolute difference from the most increased case and its relative percentage (%) when comparing the results before administration

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 12, 24, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35), 216 (day 10/day 38), 312 (day 14/day 42) hrs after administration for each period

Secondary Outcomes (8)

• Time of maximum concentration(Tmax) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Terminal half-life(t1/2) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Area Under Curve infinity(AUCinf) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Apparent Clearance(CL/F) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

• Mean Residence Time last(MRTlast) of Erythropoietin

  Twice every 10 minutes within 1hr before administration (day 1/day 29); immediately before administration; 1, 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120 (day 6/day 34), 144 (day 7/day 35) hrs after administration for each period

Study Arms (2)

EPORON→EPREX

EXPERIMENTAL

EPORON PFS(PreFilled Syringe) 4000 IU/0.4 mL(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 1. And wash out for 4 weeks. EPREX INJ.(Injection) 4000 IU(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 29.

Drug: EPORON; Drug: EPREX

EPREX→EPORON

EXPERIMENTAL

EPREX INJ. 4000 IU(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 1. And wash out for 4 weeks. EPORON PFS 4000 IU/0.4 mL(Erythropoietin alfa 4000 IU) will be administered subcutaneously after 10 hours fasting on Day 29.

Drug: EPORON; Drug: EPREX

Interventions

EPORON DRUG

single dose administration subcutaneously

Also known as: EPORON PFS 4000 IU/0.4 mL (Erythropoietin alfa 4000 IU)

EPORON→EPREX; EPREX→EPORON

EPREX DRUG

single dose administration subcutaneously

Also known as: EPREX INJ. 4000 IU (Erythropoietin alfa 4000 IU)

EPORON→EPREX; EPREX→EPORON

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers between the ages of 19\~50 at the time of screening
• Weight between 55.0kg\~90.0kg with BMI of 18.0\~27.0
• Voluntarily participants who agree to observe the precautions in writing after receiving a complete explanation of this trial

You may not qualify if:

• History of clinically significant illness related to liver (including viral hepatitis), kidney, nervous system, immune system, respiratory system, endocrine system, cardiovascular system, blood system and tumor as well as mental illness (mood disorder, obsessive-compulsive disorder, etc.)
• Hypersensitivity or clinically significant hypersensitivity to the drug (e.g. aspirin, antibiotics, etc.)
• Those whose results meet more than one of the followings in the screening including re-test; Hemoglobin level below 12g/dL or over 17g/dL, Vitamin B12 level below 200pg/mL, Ferritin level below 21.8ng/mL, Transferrin level below 190mg/dL, Reticulocyte, erythrocytes, platelets or serum potassium level over normal range
• Positive on the HIV antibody, HBsAg, HCV(Hepatitis C Virus) antibody tests
• Those whose vital signs measured in sitting position after resting over 3 minutes meet more than one of the following; Systolic BP below 90mmgHg or over 160mmgHg, Diastolic BP below 50mmgHg or over 100mmgHg, Pulse rate over 100
• History of drug abuse, or tested positive in the urine drug screening
• Administration of EPO(erythropoietin), darbepoetin or other EPO protein supply, immunoglobulin within 3 months from the scheduled first dose
• Hypersensitivity to EPO, darbepoetin or excipient in the test drug or anaphylactic reaction towards iron supplement
• Those who received the following diagnosis within 6 months from the screening; Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all kinds), Chronic or uncontrollable inflammatory diseases (e.g., rheumatoid arthritis, systemic erythematosus)
• Those who took any ETC(Ethical) drugs or herbal medicine within 2 weeks, or any OTC(Over-the-counter) drugs or vitamins within a week from the scheduled first dose (However, they may be included as the trial subjects at the discretion of the investigator if other conditions are satisfactory.)
• Those who participated other clinical trials and was administered other drugs within 3 months from the scheduled first dose
• Those who bled over 400mL or donated blood within 8 weeks from the scheduled first dose
• Those who have continued drinking (exceeding 21 units/week, 1 unit = 10g of pure alcohol) or who can't abstain from alcohol during the trial period
• Those who have smoked over 10 cigarettes daily in average for the last 3 months or who can't renounce smoking during the trial period
• Those who have ingested grapefruit or caffeine containing food within 3 days from the scheduled first dose or who can't abstain from the during the trial period.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Kyung-sang Yu, MD, Ph.D

  Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• In-jin Jang, MD, Ph.D

  Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  STUDY DIRECTOR

• Hyung-gi Lee, MD, Ph.D

  Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  STUDY DIRECTOR

• Ju-yeon Cho, Ph.D

  Clinical Pharmacology Class of Seoul National University College of Medicine / Clinical Pharmacology of Seoul National University Hospital

  STUDY DIRECTOR

• Seung-hwan Lee, MD, Ph.D

  Seoul National University Hospital Clinical Trials Center / Clinical Pharmacology of Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Kyung-sang Yu, MD, Ph.D

CONTACT

82-02-2072-1920; ksyu@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 20, 2015
• Study Start: November 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

KR (1)