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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00783341
First received: October 30, 2008
Last updated: July 16, 2009
Last verified: July 2009
History of Changes

October 30, 2008
July 16, 2009
November 2008
February 2009   (final data collection date for primary outcome measure)
Safety as determined by reported adverse events, laboratory test results, and ECGs [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00783341 on ClinicalTrials.gov Archive Site
Pharmacokinetic parameters [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Subjects
  • Drug: GAP-134
  • Drug: placebo
  • Experimental: GAP-134
    Intervention: Drug: GAP-134
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00783341
3205K2-1001
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

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