HealthyPhase 1GCPGCNCT00969826
Pharmacokinetics and Pharmacodynamics of a Novel Pegylated Recombinant Human Granulocyte-Colony Stimulating Factor
A Phase 1 study of Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials Center, Seoul National University Hospital
Seoul, 110-744
About this study
Official title: A Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of GCPGC After Single Subcutaneous Administration in Healthy Male Volunteers
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).
Read the 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).
- Conditions
- Healthy
- Being tested
- GCPGC, Neulasta, Placebo
- Keywords
- GCPGC, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCPGC, Neulasta, PlaceboDrug
Also called Neulasta® (Amgen, USA; active comparator)
A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg
| Study group | Role | What they receive |
|---|---|---|
| GCPGC 30 μg/kg | Experimental | Ten volunteers were administered GCPGC 30 μg/kg or placebo (active:placebo=8:2) Receives: Drug: GCPGC, Neulasta, Placebo |
| GCPGC 100 μg/kg | Experimental | Ten volunteers were administered GCPGC 100 μg/kg or placebo (active:placebo=8:2) Receives: Drug: GCPGC, Neulasta, Placebo |
| GCPGC 300 μg/kg | Experimental | Ten volunteers would be administered GCPGC 300 μg/kg or placebo (active:placebo=8:2) Receives: Drug: GCPGC, Neulasta, Placebo |
| Neulasta 100 μg/kg | Experimental | Eight volunteers were administered Neulasta 100 μg/kg Receives: Drug: GCPGC, Neulasta, Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentration of pegfilgrastim for pharmacokinetics
Measured: 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)
Secondary outcomes (2)
Absolute Neutrophil Count (ANC)
Measured: pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d)
CD34+ Cell count
Measured: pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Investigators
- Kyung-Sang Yu, MD, PhD, Principal investigator, Seoul National University College of Medicine and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969826
- Sponsor's protocol ID
- SNUCPT08_GCPGC
- Acronym
- GCPGC
- Status last verified
- Jan 2011
- First submitted
- 29 Aug 2009
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of GCPGC After Single Subcutaneous Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00969826
- Acronym / sponsor ID
- GCPGC / SNUCPT08_GCPGC
- Conditions
- Healthy
- Keywords
- GCPGC, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GCPGC 30 μg/kg | Experimental | Drug: GCPGC, Neulasta, PlaceboTen volunteers were administered GCPGC 30 μg/kg or placebo (active:placebo=8:2) |
| GCPGC 100 μg/kg | Experimental | Drug: GCPGC, Neulasta, PlaceboTen volunteers were administered GCPGC 100 μg/kg or placebo (active:placebo=8:2) |
| GCPGC 300 μg/kg | Experimental | Drug: GCPGC, Neulasta, PlaceboTen volunteers would be administered GCPGC 300 μg/kg or placebo (active:placebo=8:2) |
| Neulasta 100 μg/kg | Experimental | Drug: GCPGC, Neulasta, PlaceboEight volunteers were administered Neulasta 100 μg/kg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCPGC, Neulasta, PlaceboAlso: Neulasta® (Amgen, USA; active comparator)A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg | Drug | GCPGC 100 μg/kg, GCPGC 30 μg/kg, GCPGC 300 μg/kg, Neulasta 100 μg/kg |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, MD, PhD principal investigator
Seoul National University College of Medicine and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2011.