Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
NCT00510029
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 | ||||