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Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

Last updated on March 14, 2019

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Study Location
Philadelphia, Pennsylvania, 19148 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arrhythmia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50
years.

- Body Mass Index (BMI) range of 18 to 30 kg/m2.

- Blood serum creatinine levels less than or equal to the upper limit of normal.

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 history of clinically important cardiac arrhythmias and familial history of long
QT syndrome or unexpected cardiac death.

- History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any
clinically important deviation from normal limits in physical examination, vital
signs, 12-lead ECGs, or clinical laboratory test results.

NCT00510029
Pfizer
Completed
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously

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