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

• ClinicalTrials.gov Identifier: NCT00510029
• Recruitment Status: Completed
• First Posted: August 1, 2007
• Last Update Posted: March 13, 2008
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: July 31, 2007
• First Posted Date: August 1, 2007
• Last Update Posted Date: March 13, 2008
• Study Start Date: September 2007
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects [ Time Frame: 3-4 months ]
• Original Primary Outcome Measures (submitted: July 31, 2007): To assess the safety and tolerability of single ascending IV doses of GAP-134 administered as 24-hour continuous infusions and as single bolus injection of GAP-134 in healthy subjects
• Current Secondary Outcome Measures (submitted: December 21, 2007): To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects [ Time Frame: 3-4 months ]
• Original Secondary Outcome Measures (submitted: July 31, 2007): To provide the initial Pharmacokinetic (PK) profile of single ascending IV doses (24 hour and 1-minute) and the initial PK assessment of the bioavailability of an oral formulation of GAP-134 under fasting conditions in healthy subjects
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Condition: Arrhythmia

Intervention

Drug: GAP-134

atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO

Study Arms

GAP-134, IV and Oral

Experimental; Active Comparator; Placebo

Intervention: Drug: GAP-134

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: July 31, 2007): 72
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00510029
• Other Study ID Numbers: 3205K2-1000
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: March 2008