Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
An Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as 6-Day Continuous Infusions to Healthy Subjects
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2008
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJuly 17, 2009
July 1, 2009
3 months
October 30, 2008
July 16, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Safety as determined by reported adverse events, laboratory test results, and ECGs
3 weeks
Secondary Outcomes (1)
Pharmacokinetic parameters
9 days
Study Arms (2)
GAP-134
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Philadelphia, Pennsylvania, 19428, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
July 17, 2009
Record last verified: 2009-07