Pharmacokinetics Study of CJ-40001 and NESP® After Single Dose Administration in Health Male Volunteers

Healthy Subjects Clinical Trial

Official title:

A Single-blind, Randomized, Single-dose, Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of CJ-40001 and NESP® in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542916
• Other study ID #: CJ_EPO_101
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: CJ HealthCare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP® in healthy male volunteers.

Description:

The purpose of this study is to compare the pharmacokinetics and safety after a single subcutaneous or intravenous administration of CJ-40001 and NESP in healthy male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male aged 19 to 55 years at the screening

• Subject with BMI between 19 kg/m2 and 28 kg/m2 (inclusive)

• Subject who is able to participate in the whole study process

• Subject who provided written informed consent voluntarily after being fully informed of the study objectives, procedures and the investigational product

Exclusion Criteria:

• Subject who has a medical history of gastrointestinal, cardiovascular, respiratory, hepatobiliary, hematologic/oncologic, neuropsychologic, endocrinological, immunologic or renal disease that may be aggravated by the investigational product

• Subject with a systolic blood pressure of equal to or greater than 140 or less than 90 mmHg or with a diastolic blood pressure of equal to or greater than 90 or less than 60 mmHg

• Subject who has allergic disease that needs to be treated

• Subject with a history of drug allergies to any ingredient of the investigational product or marketed drug

• Subject with a blood hemoglobin value less than 13 g/dL or more than 17 g/dL

• Subject with a blood reticulocyte value more than the upper reference limit

• Subject with a blood vitamin B12 or ferritin or transferrin value less than the lower reference limit

• Subject with any non-negative results in blood serology (HBV, HCV, HIV, RPR) tests and in an examination of syphilis

• Subject who smokes more than 10 cigarettes per day

• Subject who consumes alcohol more than 140 g per week

• Subject with a history of drug abuse

• Subject who was administered with any investigational product, erythropoietin or iron supplement within 60 days prior to the screening

• Subject who donated whole blood within 60 days or blood components within 30 days prior to the screening

• Subject who took any herbal medicine within 30 days or any prescription drug within 14 days or over-the-counter drug considered to affect study within 10 days prior to the screening

• Subject who does not agree to use medically acceptable methods of contraception or who has plan to provide sperm during the study period

• Subject whom the investigator determined to have clinically significant findings in ECG

• Subject whose liver function is decreased with an AST, ALT or bilirubin value more than 1.5 times the upper reference limit

• Subject whose renal function is decreased with a GFR value calculated using MDRD equation less than the lower reference limit

• Subject whom the investigator determined to have clinically significant findings in clinical laboratory test

• Subject who is inappropriate as a subject of this study by the investigator's decision

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• CJ-40001 60ug
CJ-40001 60ug SC, IV injection
• NESP 60ug
NESP 60ug SC, IV injection

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Cmax of darbepoetin alfa in SC treatment group		SC treatment:Pre-dose and after dose up to 16 days
Primary	Assess Cmax of darbepoetin alfa in IV treatment group		IV treatment:Pre-dose and after dose 12 days
Primary	Assess AUClast of darbepoetin alfa in SC treatment group		SC treatment:Pre-dose and after dose up to 16 days
Primary	Assess AUClast of darbepoetin alfa in IV treatment group		IV treatment:Pre-dose and after dose 12 days
Secondary	Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group		SC treatment:Pre-dose and after dose up to 16 days
Secondary	Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group		SC treatment:Pre-dose and after dose up to 16 days
Secondary	Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in SC treatment group		SC treatment:Pre-dose and after dose up to 16 days
Secondary	Assess Temax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group		IV treatment:Pre-dose and after dose 12 days
Secondary	Assess Emax of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group		IV treatment:Pre-dose and after dose 12 days
Secondary	Assess AUEClast of reticulocyte, hemoglobin, hematocrit, RBC in IV treatment group		IV treatment:Pre-dose and after dose 12 days