Clinical trial NCT01684605: Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Anemia
Keywords: CKD-11101
NESP
Darbepoetin alfa
Anemia
intravenous
Pharmacokinetics
Phase 1
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
First posted: 2012-09-13
Enrollment: 31
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Assess AUClast of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
measure: Assess Cmax of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
Secondary outcomes:
measure: Assess AUCinf of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
measure: Assess Tmax of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
measure: Assess t1/2 of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
measure: Assess CL of darbepoetin alfa
timeFrame: Pre-dose, 0.25h, 0.5h, 0.75h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h, 168h, 264h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Sang Yu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: