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

Phase 1

Completed

• Conditions: Anemia
• Interventions: Drug: NESP 60μg; Drug: CKD-11101 60μg

• Registration Number: NCT01685671
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Study Start: 2012-10-26
• Primary Completion: 2012-12-25
• Study Completion: 2013-01-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-22
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

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.)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NESP 60μg	NESP 60μg	Prefilled syringe filled with Darbepoetin alfa 60μg
CKD-11101 60μg	CKD-11101 60μg	Prefilled syringe filled with Darbepoetin alfa 60μg

Primary Outcome Measures

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

Name	Time	Method
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 AUCinf 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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of