A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-05280014 And Trastuzumab Sourced From US And EU Administered To Healthy Male Volunteers
2 other identifiers
interventional
105
1 country
1
Brief Summary
In this study, healthy male volunteers will receive a single intravenous administration of either PF-05280014 or trastuzumab (United States) or trastuzumab (European Union). During the course of the study, the pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-05280014 and the US-licensed and EU-approved trastuzumab products. Safety, tolerability, and immunologic response also will be evaluated throughout.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2012
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 18, 2012
December 1, 2012
7 months
May 14, 2012
December 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of PF-05280014 compared to trastuzumab-EU.
Day 1 - Day 71
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of PF-05280014 compared to trastuzumab-US.
Day 1 - Day 71
Pharmacokinetic parameters Area-Under-the-Curve (AUC) and Maximal Concentration (Cmax) of trastuzumab-EU to trastuzumab-US.
Day 1 - Day 71
Secondary Outcomes (2)
Incidence of anti-trastuzumab antibodies (ADAs), including neutralizing antibodies (Nab).
Day 1 - LSLV or Day 71 whichever occurs later
Pharmacokinetic parameters Maximal Concentration (Cmax) and Area-Under-the-Curve (AUC) for the combined groups of trastuzumab-US and trastuzumab EU.
Day 1 - Day 71
Study Arms (3)
A
EXPERIMENTALPF-05280014
B
ACTIVE COMPARATORTrastuzumab-EU
C
ACTIVE COMPARATORTrastuzumab-US
Interventions
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
Eligibility Criteria
You may qualify if:
- Healthy male subjects (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 ECG, and clinical laboratory tests). Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight \> 50 kg (110 lbs).
- Male subjects must agree that they and their female spouse/partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
- Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram (ECHO) within 8 weeks prior to randomization.
You may not qualify if:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, or clinical findings at screening excluding untreated, asymptomatic seasonal allergies at time of dosing.
- Clinically significant abnormalities in laboratory test results.
- Previous exposure to a monoclonal antibody or current use of other biologics.
- History of allergic or anaphylactic reaction to a therapeutic drug or benzyl alcohol.
- Use of prescription or non prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication.
- Other severe acute or chronic medical or psychiatric condition 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 judgment of the investigator, would make the subject inappropriate for entry into this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Publications (1)
Yin D, Barker KB, Li R, Meng X, Reich SD, Ricart AD, Rudin D, Taylor CT, Zacharchuk CM, Hansson AG. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01). Br J Clin Pharmacol. 2014 Dec;78(6):1281-90. doi: 10.1111/bcp.12464.
PMID: 25041377DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 22, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 18, 2012
Record last verified: 2012-12