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

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ClinicalTrials.gov Identifier: NCT00783341
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : July 17, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: GAP-134 Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as 6-Day Continuous Infusions to Healthy Subjects
Study Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009
Arms and Interventions
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Arm Intervention/treatment
Experimental: GAP-134 Drug: GAP-134
Placebo Comparator: placebo Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety as determined by reported adverse events, laboratory test results, and ECGs [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 9 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00783341


Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19428
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00783341     History of Changes
Other Study ID Numbers: 3205K2-1001
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: July 17, 2009
Last Verified: July 2009