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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685671
• Other study ID #: 136HPS12C
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2012
• Last updated: May 22, 2017
• Start date: October 26, 2012
• Est. completion date: January 15, 2013

Study information

• Verified date: May 2017
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 15, 2013
• Est. primary completion date: December 25, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• NESP 60µg
Administrated NESP 60µg once subcutaneously
• CKD-11101 60µg
Administrated CKD-11101 60µg once subcutaneously

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess AUClast of darbepoetin alfa		Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Primary	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	Assess AUCinf of darbepoetin alfa		Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Secondary	Assess Tmax of darbepoetin alfa		Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Secondary	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
Secondary	Assess CL of darbepoetin alfa		Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h