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

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Hospital
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01684605
First received: September 11, 2012
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Anemia
Drug: NESP 60μg
Drug: CKD-11101 60μg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After IV Administration in Health Male Volunteers

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Assess AUClast of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]
  • Assess Cmax of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess AUCinf of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]
  • Assess Tmax of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]
  • Assess t1/2 of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]
  • Assess CL of darbepoetin alfa [ Time Frame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: October 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NESP 60μg
Prefilled syringe filled with Darbepoetin alfa 60μg
Drug: NESP 60μg
Administrated NESP 60μg once intravenously
Other Name: NESP 60μg
Experimental: CKD-11101 60μg
Prefilled syringe filled with Darbepoetin alfa 60μg
Drug: CKD-11101 60μg
Administrated CKD-11101 60μg once intravenously
Other Name: CKD-11101 60μg

Detailed Description:

Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously. (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.

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684605

Locations
Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Seoul National University Hospital
Investigators
Principal Investigator: Kyung Sang Yu, Ph.D Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01684605     History of Changes
Other Study ID Numbers: 136HPS12D
Study First Received: September 11, 2012
Last Updated: March 14, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
CKD-11101
NESP
Darbepoetin alfa
Anemia
intravenous
Pharmacokinetics
Phase 1

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014