Arrhythmia
Conditions
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.
Interventions
DRUGGAP-134
atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 3-4 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 3-4 months |
Countries
United States
Outcome results
None listed