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

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

Study Overview

• Status: Unknown
• Conditions: Pharmacokinetics
• Intervention / Treatment: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States, 65802
      • Recruiting
      • QPS Bio-Kinetic
      • Contact: Dennis Morrison, DO; Phone Number: 417-831-0456

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Sequence I (DRL, A, 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B
Experimental: Treatment Sequence II (DRL, B, 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B
Experimental: Treatment Sequence III (A, DRL, 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B
Experimental: Treatment Sequence IV (A, B, DRL); 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B
Experimental: Treatment Sequence V (B, A, DRL); 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B
Experimental: Treatment Sequence VI (B, DRL, 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.	Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	105 days
AUC(0-inf)	Area under concentration-time curve extrapolated from time 0 to infinity	105 days
AUC(0-t)	Area under concentration-time curve from time 0 to the time of the last quantifiable concentration	105 days
Emax	Maximum observed effect	105 days
AUEC(0-t)	Area under the effect time curve from time zero (predose) to last measured time	105 days

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): August 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteers; Pharmacokinetics; Pharmacodynamics; Pegfilgrastim
• Other Study ID Numbers: PG-01-003