A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers

Status unconfirmed · Phase 1

Conditions studied: Pharmacokinetics

In brief

This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.

Key facts

Study ID

NCT02205320

Run by

Dr. Reddy's Laboratories Limited

People needed

192

Starts

2014-02-01

Expected to finish

2014-09-01

Last updated by the study team

2014-07-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• QPS Bio-Kinetic — Springfield, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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