A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
Phase 1
- Conditions
- Pharmacokinetics
- Interventions
- Biological: DRL_PGBiological: Pegfilgrastim Form ABiological: Pegfilgrastim Form B
- Registration Number
- NCT02205320
- Lead Sponsor
- Dr. Reddy's Laboratories Limited
- Brief Summary
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
Inclusion Criteria
-
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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment Sequence II (DRL, B, A) Pegfilgrastim Form B Patients 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 V (B, A, DRL) Pegfilgrastim Form B Patients 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 I (DRL, A, B) DRL_PG Patients 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 III (A, DRL, B) Pegfilgrastim Form A Patients 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) Pegfilgrastim Form B Patients 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 IV (A, B, DRL) Pegfilgrastim Form A Patients 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 I (DRL, A, B) Pegfilgrastim Form A Patients 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) DRL_PG Patients 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) DRL_PG Patients 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 VI (B, DRL, A) Pegfilgrastim Form B Patients 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. Treatment Sequence I (DRL, A, B) Pegfilgrastim Form B Patients 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) Pegfilgrastim Form A Patients 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 IV (A, B, DRL) DRL_PG Patients 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) DRL_PG Patients 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 III (A, DRL, B) Pegfilgrastim Form B Patients 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 V (B, A, DRL) Pegfilgrastim Form A Patients 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) DRL_PG Patients 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. Treatment Sequence VI (B, DRL, A) Pegfilgrastim Form A Patients 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.
- Primary Outcome Measures
Name Time Method AUC(0-t) 105 days Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
AUC(0-inf) 105 days Area under concentration-time curve extrapolated from time 0 to infinity
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
Cmax 105 days Maximum plasma concentration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QPS Bio-Kinetic
🇺🇸Springfield, Missouri, United States