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Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Shinagawa-Ku, Tokyo, 141-0001 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arrhythmia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy Japanese men age 20-45.

- BMI within 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
be able to abstain from smoking within 48 hours before study day 1 until the end of
the inpatient confinement period.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the test article (e.g., resection of liver,
kidney, gallbladder, or gastrointestinal tract).

- Acute disease state.

- Any history of clinically important cardiac arrhythmias. Family history of long QT
syndrome, Torsades de Pointes or unexpected cardiac death.

- Any clinically important deviation from normal limits in physical examination, vital
signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
Creatinine levels must be less than or equal to the upper limit of normal at
screening.

- Demonstration of a positive orthostatic test at screening. The definition of a
positive test is a greater than or equal to 20 mm Hg decrease in systolic blood
pressure, greater than or equal to 10 mm Hg decrease in diastolic blood pressure, or a
greater than or equal to 30 bpm increase in pulse rate, after standing for 3 minutes.

- Positive serologic findings for human immunodeficiency virus (HIV) antigen and
antibodies, hepatitis B surface antigen (HbsAg), and/or hepatitis C virus (HCV)
antibodies.

- Positive findings of urine drug screen.

- History of any clinically important drug allergy or adverse drug reaction (e.g.,
relapsing dermatitis, drug hypersensitivity, drug allergy, hypersensitivity to
ingredient in the test articles or angioedemas)

- Use of any investigational drug within 90 days before study day 1 or prescription drug
within 30 days before study day 1.

- Consumption of any caffeine-containing products.

- Consumption of grapefruit or grapefruit-containing products within 72 hours before
study day 1 until the end of the inpatient confinement period.

- Use of any over-the-counter drugs, including herbal supplements (except for the
occasional use of vitamins less than or equal to 100% of the recommended daily
allowance), within 14 days before study day 1.

NCT00543946
Pfizer
Completed
Single Ascending Dose of GAP-134 as a 24-hour IV Infusion in Healthy Japanese Males

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Pfizer Clinical Trials Contact Center

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[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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