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A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 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.
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- Body Mass Index (BMI) of 17.5 to 30.5 kg^m2; and a total body weight >50 kg (110 lbs).

- Left ventricular ejection fraction (LVEF) within the normal range as measured by
echocardiogram (ECHO) within 8 weeks prior to randomization.

- Subjects who have previously been exposed to a biologic agent (other than a HER2
inhibitor) may enroll provided that at least 3 months have passed since the last
administration of that drug.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Previous exposure to an anti-HER2 antibody.

- History of serious allergic or anaphylactic reaction to a therapeutic drug or benzyl
alcohol.

NCT02015156
Pfizer
Completed
A Study Evaluating The Safety Of PF-05280014 And Trastuzumab In Healthy Male Volunteers (REFLECTIONS B327-06)

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