Pharmacokinetics Study of CKD-11101 and NESP After SC Administration in Health Male Volunteers

NCT ID: NCT01685671

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-26
• Study Completion Date: 2013-01-15

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers

Detailed Description

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NESP 60μg

Prefilled syringe filled with Darbepoetin alfa 60μg

Group Type: ACTIVE_COMPARATOR

NESP 60μg

Intervention Type: DRUG

Administrated NESP 60μg once subcutaneously

CKD-11101 60μg

Prefilled syringe filled with Darbepoetin alfa 60μg

Group Type: EXPERIMENTAL

CKD-11101 60μg

Intervention Type: DRUG

Administrated CKD-11101 60μg once subcutaneously

Interventions

NESP 60μg

Administrated NESP 60μg once subcutaneously

Intervention Type: DRUG

CKD-11101 60μg

Administrated CKD-11101 60μg once subcutaneously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed the informed consent form prior to study participation.
• A healthy male volunteer between 20 and 55 years old.
• Body weight between 55kg and 90kg, BMI between 18 and 27.
• Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)

Exclusion Criteria

• Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
• Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
• Have abnormal laboratory result.

• Hemoglobin < 12g/dL or > 17g/dL
• Vitamin B12 < 200pg/mL
• Ferritin < 21.8ng/mL
• Transferrin < 190mg/dL
• Reticulocyte over the normal limit
• Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
• Positive for HIV antibody, HBsAg, HCV antibody test
• A heavy smoker (cigarette > 10 cigarettes per day)
• Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
• Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
• sit SBP < 90mmHg or sit SBP > 140mmHg or sit DBP < 55mmHg or sit DBP > 90mmHg or Pulse rate > 100 per/min
• History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
• Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
• Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
• A heavy alcohol consumer (alcohol > 21 units/week) or cannot stop drinking
• Bleed or donate blood (> 400mL) within 8 weeks before the first IP administration
• Participated in this clinical trials and administrated IP
• Have a diet within 2 days before the first IP administration or cannot stop having

• food containing grapefruit
• food containing caffeine
• Disagree to avoid getting pregnant during clinical trial
• An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyung Sang Yu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul national university hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

136HPS12C

Identifier Type: -

Identifier Source: org_study_id