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

Pharmacokinetics Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02205320
• Other study ID #: PG-01-003
• Status: Recruiting
• Phase: Phase 1
• First received: July 29, 2014
• Last updated: July 29, 2014
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: July 2014
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Biological:
• DRL_PG

• Pegfilgrastim Form A

• Pegfilgrastim Form B

Locations

Country	Name	City	State
United States	QPS Bio-Kinetic	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration	105 days	No
Primary	AUC(0-inf)	Area under concentration-time curve extrapolated from time 0 to infinity	105 days	No
Primary	AUC(0-t)	Area under concentration-time curve from time 0 to the time of the last quantifiable concentration	105 days	No
Primary	Emax	Maximum observed effect	105 days	No
Primary	AUEC(0-t)	Area under the effect time curve from time zero (predose) to last measured time	105 days	No