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Study Evaluating Single Doses of GAP-134

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
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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- Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive at
screening.

- WONCBP may be included if they are either surgically sterile (hysterectomy and/or
oophorectomy) or postmenopausal for ≥1 year (with follicle stimulating hormone [FSH]
level ≥38 mIU/mL) and must have a negative pregnancy test result within 24 hours
before administration of the study drug or placebo.

- Women who are surgically sterile must provide documentation of the procedure by an
operative report or by an ultrasound scan report.

- Sexually active men must agree to use a medically acceptable form of contraception
during the study and continue using it for 12 weeks after study drug or placebo
administration.

- Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg.

- Healthy as determined by the investigator on the basis of medical history, physical
examination, clinical laboratory test results, vital sign measurements, and 12-lead
electrocardiogram (ECG).

- Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24
mg/dL.)

- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must
be able to abstain from smoking during the inpatient stay.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Presence or history of any disorder that may prevent the successful completion of the
study.

- 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 study drug or placebo.

- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
administration of study drug or placebo.

- Any history of clinically important cardiac arrhythmias.

- Familial history of long QT syndrome or unexpected cardiac death.

- History of drug abuse within 1 year before before administration of study drug or
placebo.

NCT00820521
Pfizer
Withdrawn
Study Evaluating Single Doses of GAP-134

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