A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
1 other identifier
interventional
192
1 country
1
Brief Summary
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedJuly 31, 2014
July 1, 2014
6 months
July 29, 2014
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Cmax
Maximum plasma concentration
105 days
AUC(0-inf)
Area under concentration-time curve extrapolated from time 0 to infinity
105 days
AUC(0-t)
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
105 days
Emax
Maximum observed effect
105 days
AUEC(0-t)
Area under the effect time curve from time zero (predose) to last measured time
105 days
Study Arms (6)
Treatment Sequence I (DRL, A, B)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: DRL\_PG, Pegfilgrastim Form A, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
Treatment Sequence II (DRL, B, A)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: DRL\_PG, Pegfilgrastim Form B, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
Treatment Sequence III (A, DRL, B)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, DRL\_PG, Pegfilgrastim Form B. Each drug is administered as a single, 6 mg, subcutaneous injection.
Treatment Sequence IV (A, B, DRL)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form A, Pegfilgrastim Form B, DRL\_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
Treatment Sequence V (B, A, DRL)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, Pegfilgrastim Form A, DRL\_PG. Each drug is administered as a single, 6 mg, subcutaneous injection.
Treatment Sequence VI (B, DRL, A)
EXPERIMENTALPatients will receive study drugs in the following cross-over sequence: Pegfilgrastim Form B, DRL\_PG, Pegfilgrastim Form A. Each drug is administered as a single, 6 mg, subcutaneous injection.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female subjects aged 18 to 55 years
- A standardized body mass index
- General good health as determined by the Investigator
- Normal organ function as per the Investigator's judgement
- Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
- Female subjects must:
- Not be lactating; not be pregnant
- Agree to use an acceptable contraceptive method or be of non-childbearing potential
- Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug
You may not qualify if:
- Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
- Presence of antibodies to polyethylene glycol at screening
- Positive result for cotinine (\>500 ng/mL) or drugs of abuse at screening or on admission
- Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
- Donation of blood (≥500 mL) or plasma within the previous 3 months
- History of unexplained syncopal episodes;
- Any disorder that, in the Investigator's opinion, may interfere with study compliance
- History of any cancer
- History of pulmonary infiltrate or pneumonia within the previous 6 months from screening visit
- Hereditary fructose and/or sorbitol intolerance
- Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or 2
- Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically significant and/or suggestive of underlying cardiac abnormalities
- A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by the Investigator, or thyroid abnormalities
- Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or with sickle cell disease
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
QPS Bio-Kinetic
Springfield, Missouri, 65802, United States
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
July 29, 2014
First Posted
July 31, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
July 31, 2014
Record last verified: 2014-07