For Healthcare Professionals

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

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Healthy male and female subjects aged 18 to 55 years
  2. A standardized body mass index
  3. General good health as determined by the Investigator
  4. Normal organ function as per the Investigator's judgement
  5. Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
  6. Female subjects must:
  7. Not be lactating; not be pregnant
  8. Agree to use an acceptable contraceptive method or be of non-childbearing potential
  9. Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug

EXCLUSION CRITERIA

  1. Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
  2. Presence of antibodies to polyethylene glycol at screening
  3. Positive result for cotinine (>500 ng/mL) or drugs of abuse at screening or on admission
  4. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
  5. Donation of blood (≥500 mL) or plasma within the previous 3 months
  6. History of unexplained syncopal episodes;
  7. Any disorder that, in the Investigator's opinion, may interfere with study compliance
  8. History of any cancer
  9. History of pulmonary infiltrate or pneumonia within the previous 6 months from screening visit
  10. Hereditary fructose and/or sorbitol intolerance
  11. Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening
  12. Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or 2
  13. Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically significant and/or suggestive of underlying cardiac abnormalities
  14. A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by the Investigator, or thyroid abnormalities
  15. Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or with sickle cell disease
  16. 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
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Pharmacokinetics

Age

18+

Phase

Phase 1

Participants needed

192

Est. Completion Date

Sep 2014

Treatment type

Interventional


Sponsor

Dr. Reddy's Laboratories Limited

ClinicalTrials.gov identifier

NCT02205320

Study number

PG-01-003

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