A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
NCT ID: NCT02205320
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
192 participants
INTERVENTIONAL
2014-02-28
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
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.
DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
Interventions
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DRL_PG
Pegfilgrastim Form A
Pegfilgrastim Form B
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
Yes
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Locations
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QPS Bio-Kinetic
Springfield, Missouri, United States
Countries
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Facility Contacts
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Dennis Morrison, DO
Role: primary
Other Identifiers
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PG-01-003
Identifier Type: -
Identifier Source: org_study_id