Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
NCT00510029
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- Generally healthy men and women of nonchildbearing potential (WONCBP), aged 18 to 50 years.
- Body Mass Index (BMI) range of 18 to 30 kg/m2.
- Blood serum creatinine levels less than or equal to the upper limit of normal.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any history of clinically important cardiac arrhythmias and familial history of long
QT syndrome or unexpected cardiac death.
- History of drug and alcohol abuse, positive HIV, HCV, and/or HBs Ag test, and any
clinically important deviation from normal limits in physical examination, vital
signs, 12-lead ECGs, or clinical laboratory test results.
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Descriptive Information | ||||
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Brief Title ICMJE | Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously | |||
Official Title ICMJE | Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously as a 24-Hour Infusion to Healthy Subjects. | |||
Brief Summary | The study will assess the safety, tolerability and pharmacokinetics of single intravenous (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour infusion. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) | |||
Condition ICMJE | Arrhythmia | |||
Intervention ICMJE | Drug: GAP-134
atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO | |||
Study Arms ICMJE | GAP-134, IV and Oral
Experimental; Active Comparator; Placebo Intervention: Drug: GAP-134 | |||
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 | |||
Estimated Enrollment ICMJE | 72 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2008 | |||
Actual Primary Completion Date | January 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
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 | NCT00510029 | |||
Other Study ID Numbers ICMJE | 3205K2-1000 | |||
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 |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | March 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |