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

July 29, 2014 updated by: Dr. Reddy's Laboratories Limited
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 105 days
Maximum plasma concentration
105 days
AUC(0-inf)
Time Frame: 105 days
Area under concentration-time curve extrapolated from time 0 to infinity
105 days
AUC(0-t)
Time Frame: 105 days
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
105 days
Emax
Time Frame: 105 days
Maximum observed effect
105 days
AUEC(0-t)
Time Frame: 105 days
Area under the effect time curve from time zero (predose) to last measured time
105 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Reddy's Laboratories Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PG-01-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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