NCT01685671

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2012

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2013

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

2 months

First QC Date

September 12, 2012

Last Update Submit

May 22, 2017

Conditions

Anemia

Keywords

CKD-11101NESPDarbepoetin alfaAnemiasubcutaneousPharmacokineticsPhase 1

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

NESP 60μg

ACTIVE COMPARATOR

Prefilled syringe filled with Darbepoetin alfa 60μg

Drug: NESP 60μg

CKD-11101 60μg

EXPERIMENTAL

Prefilled syringe filled with Darbepoetin alfa 60μg

Drug: CKD-11101 60μg

Interventions

NESP 60μgDRUG

Administrated NESP 60μg once subcutaneously

NESP 60μg
CKD-11101 60μgDRUG

Administrated CKD-11101 60μg once subcutaneously

CKD-11101 60μg

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Kyung Sang Yu, Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

October 26, 2012

Primary Completion

December 25, 2012

Study Completion

January 15, 2013

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

KR(1)