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

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NCT00783341

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Study Location
Philadelphia, Pennsylvania, 19428, United States
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1-800-718-1021
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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Official Title  ICMJE An Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as 6-Day Continuous Infusions to Healthy Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: GAP-134
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: GAP-134
    Intervention: Drug: GAP-134
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2009)		25
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2008)		24
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  1. Men or women of non childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening.
  2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ?50 kg.
  3. 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).
  4. Serum creatinine level must be less than 1.30 mg/dL. (Normal range: 0.44 to 1.24 mg/dL.)
  5. 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

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  3. Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the test article.
  4. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
  5. Any history of clinically important cardiac arrhythmias.
  6. Familial history of long QT syndrome or unexpected cardiac death.
  7. History of drug abuse within 1 year before study day 1.
  8. History of alcoholism within 1 year before study day 1.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00783341
Other Study ID Numbers  ICMJE 3205K2-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP