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A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

Last updated on March 15, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01603264
Pfizer
Completed
A Pharmacokinetic Study Comparing PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-01)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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