A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | May 2012 |
| End Date: | November 2012 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
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
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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