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

Dr.Reddy's Laboratories

Status and phase: Unknown; Phase 1

Conditions: Pharmacokinetics

Treatments: Biological: Pegfilgrastim Form B; Biological: DRL_PG; Biological: Pegfilgrastim Form A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02205320

PG-01-003

Details and patient eligibility

About

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

Enrollment: 192 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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192 participants in 6 patient groups

Treatment Sequence I (DRL, A, B)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A

Treatment Sequence II (DRL, B, A)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A

Treatment Sequence III (A, DRL, B)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A

Treatment Sequence IV (A, B, DRL)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A

Treatment Sequence V (B, A, DRL)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A

Treatment Sequence VI (B, DRL, A)

Experimental group

Description:

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:

Biological: Pegfilgrastim Form B

Biological: DRL_PG

Biological: Pegfilgrastim Form A