Status:
COMPLETED
Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending doses of GAP 134 administered as 6-day continuous IV infusions to healthy subjects.
Eligibility Criteria
Inclusion
- Inclusion
- Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
- 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
- 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 distribution, metabolism, or excretion of the test article.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
- 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 study day 1.
- History of alcoholism within 1 year before study day 1.
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00783341
Start Date
November 1 2008
End Date
February 1 2009
Last Update
July 17 2009
Active Locations (1)
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1
Philadelphia, Pennsylvania, United States, 19428