Pharmacokinetics
Conditions
Keywords
Pegfilgrastim, Pharmacokinetics, Pharmacodynamics, Healthy volunteers
Brief summary
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
Interventions
BIOLOGICALPegfilgrastim Form A
BIOLOGICALPegfilgrastim Form B
BIOLOGICALDRL_PG
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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: * Not be lactating; not be pregnant * Agree to use an acceptable contraceptive method or be of non-childbearing potential 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 105 days | Maximum plasma concentration |
| AUC(0-inf) | 105 days | Area under concentration-time curve extrapolated from time 0 to infinity |
| AUC(0-t) | 105 days | Area under concentration-time curve from time 0 to the time of the last quantifiable concentration |
| Emax | 105 days | Maximum observed effect |
| AUEC(0-t) | 105 days | Area under the effect time curve from time zero (predose) to last measured time |
Countries
United States
Outcome results
None listed