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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Subjects | Drug: GAP-134 Drug: placebo | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: GAP-134 | Drug: GAP-134 |
Placebo Comparator: placebo | Drug: placebo |
- Safety as determined by reported adverse events, laboratory test results, and ECGs [ Time Frame: 3 weeks ]
- Pharmacokinetic parameters [ Time Frame: 9 days ]

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

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
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19428 |
Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
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 |