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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02205320
Other study ID # PG-01-003
Secondary ID
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


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
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