Status:
UNKNOWN
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Any prescribed or over the counter medications including analgesics, herbal remedies, vitamin therapy must not be used from 7 days prior to the first administration of study drugs
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT02205320
Start Date
February 1 2014
End Date
September 1 2014
Last Update
July 31 2014
Active Locations (1)
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1
QPS Bio-Kinetic
Springfield, Missouri, United States, 65802