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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: NESP 60μg
* Drug: CKD-11101 60μg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Darbepoetin alfa, CKD-11101, NESP, subcutaneous, Pharmacokinetics, Phase 1