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

A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health Male Volunteers

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

Study Overview

• Status: Completed
• Conditions: Anemia
• Intervention / Treatment: Drug: NESP 60μg; Drug: CKD-11101 60μg

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: NESP 60μg; Prefilled syringe filled with Darbepoetin alfa 60μg	Drug: NESP 60μg; Administrated NESP 60μg once subcutaneously
Experimental: CKD-11101 60μg; Prefilled syringe filled with Darbepoetin alfa 60μg	Drug: CKD-11101 60μg; Administrated CKD-11101 60μg once subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess AUClast of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Cmax of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess AUCinf of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess Tmax of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess t1/2 of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess CL of darbepoetin alfa	Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Collaborators: Seoul National University Hospital
• Investigators: Principal Investigator: Kyung Sang Yu, Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2012
• Primary Completion (Actual): December 25, 2012
• Study Completion (Actual): January 15, 2013

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 14, 2012

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Anemia; CKD-11101; NESP; Darbepoetin alfa; subcutaneous; Phase 1
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: 136HPS12C

Drug and device information, study documents

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