Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor (GCPGC)

This study has been completed.
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00969826
First received: August 29, 2009
Last updated: January 9, 2011
Last verified: January 2011
  Purpose

This study is a four arm, parallel study.

Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).


Condition Intervention Phase
Healthy
Drug: GCPGC, Neulasta, Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of GCPGC After Single Subcutaneous Administration in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Blood concentration of pegfilgrastim for pharmacokinetics [ Time Frame: pre-dose, 3, 6, 9, 12, 24(2d), 36, 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute Neutrophil Count (ANC) [ Time Frame: pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) ] [ Designated as safety issue: No ]
  • CD34+ Cell count [ Time Frame: pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) ] [ Designated as safety issue: No ]

Estimated Enrollment: 38
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GCPGC 30 μg/kg
Ten volunteers were administered GCPGC 30 μg/kg or placebo (active:placebo=8:2)
Drug: GCPGC, Neulasta, Placebo
A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
Other Name: Neulasta® (Amgen, USA; active comparator)
Experimental: GCPGC 100 μg/kg
Ten volunteers were administered GCPGC 100 μg/kg or placebo (active:placebo=8:2)
Drug: GCPGC, Neulasta, Placebo
A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
Other Name: Neulasta® (Amgen, USA; active comparator)
Experimental: GCPGC 300 μg/kg
Ten volunteers would be administered GCPGC 300 μg/kg or placebo (active:placebo=8:2)
Drug: GCPGC, Neulasta, Placebo
A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
Other Name: Neulasta® (Amgen, USA; active comparator)
Experimental: Neulasta 100 μg/kg
Eight volunteers were administered Neulasta 100 μg/kg
Drug: GCPGC, Neulasta, Placebo
A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
Other Name: Neulasta® (Amgen, USA; active comparator)

Detailed Description:

Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9, Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: Between 20 to 40 years of age, inclusive (Age based on the date to give the informed consent)
  • Weight: Between 60 - 75 kg, within ±20% of ideal body weight
  • Normal clinical laboratory findings, especially for ANC value between 2000 to 7500, inclusive
  • Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Exclusion Criteria:

  • History of hypersensitive reaction to medication (aspirin, antibiotics)
  • History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
  • History or evidence of drug abuse
  • Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
  • Participation in clinical trials of any drug within 60 days prior to the participation of the study
  • Donation of whole blood within 60 days or a unit of blood within 30 days prior to the start of study
  • Judged to be inappropriate for the study by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969826

Locations
Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Green Cross Corporation
Investigators
Principal Investigator: Kyung-Sang Yu, MD, PhD Seoul National University College of Medicine and Hospital
  More Information

No publications provided

Responsible Party: Young-Joo Ahn, Clinical Research Team / Development Division Associate Director
ClinicalTrials.gov Identifier: NCT00969826     History of Changes
Other Study ID Numbers: SNUCPT08_GCPGC
Study First Received: August 29, 2009
Last Updated: January 9, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
GCPGC
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014