HealthyPhase 1NCT03398473
A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects
A Phase 1 study testing Epoetin Hospira SDV and Epoetin Hospira MDV in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Epoetin Hospira SDV and Epoetin Hospira MDV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2018to 7 May 2018
- 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 female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram, or clinical laboratory tests.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state.
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure.
- Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), cancer, (except for basal cell carcinoma of skin), erythrocytosis, or seizures.
- Any condition possibly affecting drug absorption (e.g. gastrectomy).
- History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
- A positive urine drug screen.
- Use of tobacco or nicotine-containing products within 3 months of Screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).
- Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including benzyl alcohol and any other related drugs).
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- Any previous use of epoetin.
- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 oz. [150 mL] of wine or as oz. [360 mL] of beer or 1.5 oz. [45 mL] of hard liquor) within 6 months before Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceeding the fits dose of investigational product (whichever is longer).
- Screening supine BP >= 140 mmHg (systolic) or >=90 mmHg (Diastolic), following at least 5 minutes of supine rest. If BP >= 140 mmHg (systolic) or >= 90 mmHg (Diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the subject's eligibility.
- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval> 450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.
- Subject's with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) OR alanine aminotransferase (ALT) leve l>= 1.5 X upper limit of normal (ULN);
- Total bilirubin level 1.5 X ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.
- Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outline in the protocol for the duration of the study and for at least 30 days after the last dose of investigational product.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product. As exceptions, acetaminophen/paracetamol may be used at doses of <= 1 g/day and hormonal contraceptives will be allowed. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- A subject who has been administered a drug by depot injection within 30 days prior to the initial study drug administration or 6 half-lives of that drug, whichever is longer and at the discretion of the investigator, or who has received a recent (6 weeks prior to admission to the CRU) live or attenuated vaccination, or exposure to communicable viral diseases such as chicken pox, varicella, and measles.
- Blood donation (excluding plasma donations) or approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- History of HIV, hepatitis B, or hepatitis C, positive testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), or hepatitis C antibody (HCVAb).
- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of the protocol.
- Subjects who are investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study.
- May not be able to comply with the requirements of this clinical trial or be able to communicate effectively with study personnel, or is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open-label, Randomized, Single Dose, Crossover Study Evaluating The Pharmacokinetics Of Epoetin Following Administration Of Epoetin Hospira Multiple Dose Vial (Mdv) Product Compared To Epoetin Hospira Single Dose Vial (Sdv) Product As Subcutaneous Injection To Normal Healthy Subjects
This study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.
- Conditions
- Healthy
- Being tested
- Epoetin Hospira SDV, Epoetin Hospira MDV
- Keywords
- Epoetin Hospira, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin Hospira SDVDrug
Epoetin Hospira Single Dose Vial
Epoetin Hospira MDVDrug
Epoetin Hospira Multi-Dose Vial
| Study group | Role | What they receive |
|---|---|---|
| Epoetin Hospira SDV | Experimental | Epoetin Hospira Single Dose Vial (SDV) Receives: Drug: Epoetin Hospira SDV |
| Epoetin Hospira MDV | Experimental | Epoetin Hospira Multi-Dose Vial (MDV) Receives: Drug: Epoetin Hospira MDV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (C max) of PF-06946151 SDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Maximum serum concentration (C max) of PF-06946151 MDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Secondary outcomes (10)
Time to reach maximum concentration (T max) of PF-06946151 SDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 MDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 SDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 MDV
Measured: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Number of subjects with adverse events (AEs) by severity and relationship to treatment
Measured: Day 1 through approximately Day 30 after Period 2
Number of subjects with abnormal physical exam findings
Measured: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Anti-Drug Antibodies
Measured: Day 1 through approximately Day 30 after Period 2
Number of subjects with change from baseline in laboratory results
Measured: Day 1 through approximately Day 30 after Period 2
Number of subjects with clinically relevant changes in vital signs since baseline
Measured: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Neutralizing Antibodies
Measured: Day 1 through approximately Day 30 after Period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start25 Jan 2018
- Primary completion11 Apr 2018
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398473
- Sponsor's protocol ID
- C3461009
- Status last verified
- May 2018
- First submitted
- 8 Jan 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Single Dose, Crossover Study Evaluating The Pharmacokinetics Of Epoetin Following Administration Of Epoetin Hospira Multiple Dose Vial (Mdv) Product Compared To Epoetin Hospira Single Dose Vial (Sdv) Product As Subcutaneous Injection To Normal Healthy Subjects
- ClinicalTrials.gov ID
- NCT03398473
- Acronym / sponsor ID
- C3461009
- Conditions
- Healthy
- Keywords
- Epoetin Hospira, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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 study will assess the PK similarity of epoetin administered as Hospira MDV versus Hospira SDV by conducting a single-dose comparative evaluation in normal healthy subjects enrolled at a single center.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epoetin Hospira SDV | Experimental | Drug: Epoetin Hospira SDVEpoetin Hospira Single Dose Vial (SDV) |
| Epoetin Hospira MDV | Experimental | Drug: Epoetin Hospira MDVEpoetin Hospira Multi-Dose Vial (MDV) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy female and male subjects who, at time of Screening, are between ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram, or clinical laboratory tests.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (23 listed)
- Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), cancer, (except for basal cell carcinoma of skin), erythrocytosis, or seizures.
- Any condition possibly affecting drug absorption (e.g. gastrectomy).
- History of bleeding ulcer, bleeding abnormalities or coagulation abnormalities.
- A positive urine drug screen.
- Use of tobacco or nicotine-containing products within 3 months of Screening or a positive urine cotinine test (ie, active smokers and those who currently use nicotine-containing products are excluded from participation in this study).
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 |
|---|---|---|
| Epoetin Hospira SDVEpoetin Hospira Single Dose Vial | Drug | Epoetin Hospira SDV |
| Epoetin Hospira MDVEpoetin Hospira Multi-Dose Vial | Drug | Epoetin Hospira MDV |
Primary outcome
Maximum serum concentration (C max) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Maximum serum concentration (C max) of PF-06946151 MDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 SDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the serum PF-06946151 MDV concentration-time profile (AUC last) from time 0 to the last quantifiable concentration (C last)
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 SDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
Area under the PF-06946151 MDV concentration-time profile (AUC inf) from time zero extrapolated to infinity
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]
10 secondary outcomes
Time to reach maximum concentration (T max) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Time to reach maximum concentration (T max) of PF-06946151 MDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 SDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Elimination half life (T 1/2) of PF-06946151 MDV
Time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96 and 120 hours after dose administration]
Number of subjects with adverse events (AEs) by severity and relationship to treatment
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with abnormal physical exam findings
Time frame: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Anti-Drug Antibodies
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with change from baseline in laboratory results
Time frame: Day 1 through approximately Day 30 after Period 2
Number of subjects with clinically relevant changes in vital signs since baseline
Time frame: Day 1 through approximately Day 30 after Period 2
Percentage of subjects with the development of Neutralizing Antibodies
Time frame: Day 1 through approximately Day 30 after Period 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Epoetin Hospira SDV and Epoetin Hospira MDV in people with Healthy, run by Pfizer 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 8 inclusion and 23 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: finished, as of the sponsor's last update on 17 May 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum serum concentration (C max) of PF-06946151 SDV (time frame: [Time Frame: 0, 0.5, 3, 6, 9, 12, 15, 24, 30, 36, 48, 72, 96, and 120 hours after dose administration]). The study lists 6 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 17 May 2018.