PharmacokineticsPhase 1NCT02205320
A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
A Phase 1 study testing DRL_PG, Pegfilgrastim Form A and Pegfilgrastim Form B in people with Pharmacokinetics, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
Trial summary
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- DRL_PG, Pegfilgrastim Form A and Pegfilgrastim Form B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 18 to 55 years
- A standardized body mass index
- General good health as determined by the Investigator
- Normal organ function as per the Investigator's judgement
- Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
- Female subjects must:
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- Not be lactating; not be pregnant
- Agree to use an acceptable contraceptive method or be of non-childbearing potential
- Male subjects must refrain from donating sperm or fathering a child during the study and until 3 months after the last study drug
Who cannot join
- Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
- Presence of antibodies to polyethylene glycol at screening
- Positive result for cotinine (>500 ng/mL) or drugs of abuse at screening or on admission
- Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
- Donation of blood (≥500 mL) or plasma within the previous 3 months
- History of unexplained syncopal episodes;
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- Any disorder that, in the Investigator's opinion, may interfere with study compliance
- History of any cancer
- History of pulmonary infiltrate or pneumonia within the previous 6 months from screening visit
- Hereditary fructose and/or sorbitol intolerance
- Absolute neutrophil count below 1500/mm3 or above 12000/mm3 at screening
- Positive test for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) 1 or 2
- Any abnormality in 12-lead ECG that in the Investigator's opinion is clinically significant and/or suggestive of underlying cardiac abnormalities
- A clinical diagnosis of hypertension, significant hypercholesterolemia as judged by the Investigator, or thyroid abnormalities
- Family history of acute myeloid leukemia or subjects with splenomegaly at baseline, or with sickle cell disease
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
QPS Bio-Kinetic
Springfield, Missouri, 65802
Dennis Morrison, DO, 417-831-0456
About this study
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
- Conditions
- Pharmacokinetics
- Being tested
- DRL_PG, Pegfilgrastim Form A, Pegfilgrastim Form B
- Keywords
- Pegfilgrastim, Pharmacokinetics, Pharmacodynamics, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRL_PGBiological
Pegfilgrastim Form ABiological
Pegfilgrastim Form BBiological
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence I (DRL, A, B) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
| Treatment Sequence II (DRL, B, A) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
| Treatment Sequence III (A, DRL, B) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
| Treatment Sequence IV (A, B, DRL) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
| Treatment Sequence V (B, A, DRL) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
| Treatment Sequence VI (B, DRL, A) | Experimental | 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. Receives: Biological: DRL_PG; Biological: Pegfilgrastim Form A; Biological: Pegfilgrastim Form B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration
Measured: 105 days
AUC(0-inf)
Area under concentration-time curve extrapolated from time 0 to infinity
Measured: 105 days
AUC(0-t)
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
Measured: 105 days
Emax
Maximum observed effect
Measured: 105 days
AUEC(0-t)
Area under the effect time curve from time zero (predose) to last measured time
Measured: 105 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205320
- Sponsor's protocol ID
- PG-01-003
- Status last verified
- Jul 2014
- First submitted
- 29 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Crossover, Pharmacokinetic, Pharmacodynamic and Safety Study of Three Forms of PEG-G-CSF in Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02205320
- Acronym / sponsor ID
- PG-01-003
- Conditions
- Pharmacokinetics
- Keywords
- Pegfilgrastim, Pharmacokinetics, Pharmacodynamics, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a comparative pharmacokinetic, pharmacodynamic and safety study in healthy volunteers with three forms of pegylated granulocyte colony stimulating factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence I (DRL, A, B) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
| Treatment Sequence II (DRL, B, A) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
| Treatment Sequence III (A, DRL, B) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
| Treatment Sequence IV (A, B, DRL) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
| Treatment Sequence V (B, A, DRL) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
| Treatment Sequence VI (B, DRL, A) | Experimental | Biological: DRL_PG, Biological: Pegfilgrastim Form A, Biological: Pegfilgrastim Form BPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects aged 18 to 55 years
- A standardized body mass index
- General good health as determined by the Investigator
- Normal organ function as per the Investigator's judgement
- Must be non-smokers, or ex-smokers who have not smoked within the previous 6 months from the screening visit
Key exclusion criteria (16 listed)
- Known hypersensitivity to Escherichia coli derived proteins, pegfilgrastim, filgrastim or any other related component
- Presence of antibodies to polyethylene glycol at screening
- Positive result for cotinine (>500 ng/mL) or drugs of abuse at screening or on admission
- Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator
- Donation of blood (≥500 mL) or plasma within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DRL_PG | Biological | Treatment Sequence I (DRL, A, B), Treatment Sequence II (DRL, B, A), Treatment Sequence III (A, DRL, B), Treatment Sequence IV (A, B, DRL), Treatment Sequence V (B, A, DRL), Treatment Sequence VI (B, DRL, A) |
| Pegfilgrastim Form A | Biological | Treatment Sequence I (DRL, A, B), Treatment Sequence II (DRL, B, A), Treatment Sequence III (A, DRL, B), Treatment Sequence IV (A, B, DRL), Treatment Sequence V (B, A, DRL), Treatment Sequence VI (B, DRL, A) |
| Pegfilgrastim Form B | Biological | Treatment Sequence I (DRL, A, B), Treatment Sequence II (DRL, B, A), Treatment Sequence III (A, DRL, B), Treatment Sequence IV (A, B, DRL), Treatment Sequence V (B, A, DRL), Treatment Sequence VI (B, DRL, A) |
Primary outcome
Cmax
Time frame: 105 days
Maximum plasma concentration
AUC(0-inf)
Time frame: 105 days
Area under concentration-time curve extrapolated from time 0 to infinity
AUC(0-t)
Time frame: 105 days
Area under concentration-time curve from time 0 to the time of the last quantifiable concentration
Emax
Time frame: 105 days
Maximum observed effect
AUEC(0-t)
Time frame: 105 days
Area under the effect time curve from time zero (predose) to last measured time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DRL_PG, Pegfilgrastim Form A and Pegfilgrastim Form B in people with Pharmacokinetics, run by Dr. Reddy's Laboratories Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 105 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014.