Atrial Fibrillation
Conditions
Brief summary
Assess the tolerability and safety of a rapid bolus of tecadenoson at different dose levels when given alone and in combination with a beta-blocker (esmolol) in patients with atrial fibrillation to control rapid heart rate. Explore the pharmacokinetic and pharmacodynamic effects when given alone and in combination with beta-blocker (esmolol).
Interventions
DRUGTecadenoson
Tecadenoson administered intravenously (i.v.)
DRUGEsmolol
Esmolol low dose infusion according to manufacturer's instructions
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of atrial fibrillation in need of treatment for rate control * Be able and willing to abstain from any antiarrhythmics, including atrioventricular (AV) nodal blocking agents (except for esmolol per protocol), from no later than 8:00 p.m. on the day prior to dosing until completion of the last dose period assessment * Be able and willing to abstain from xanthine- or chocolate-containing foods, beverages, and medications * Females must be post-menopausal or sterilized; or if of childbearing potential, must not be breastfeeding and must have a negative pregnancy test at screening and no intention of becoming pregnant during the course of the study. Males and females must be using adequate contraception during the study.
Exclusion criteria
* Have a known accessory pathway * Have active myocardial ischemia or recent acute coronary syndrome * Have acute or overt heart failure, bradycardia, heart block greater than first degree, or cardiogenic shock * Have allergies or contraindications to treatment with esmolol or aminophylline, or any of their constituents * Have a supine cuff systolic blood pressure \< 90 mm Hg * Be undergoing treatment with theophylline/aminophylline preparations, Trental® (pentoxifylline), or carbamazepine * Have asthma or other reactive airways disease currently on-treatment * Have a history of an active or chronic pancreatic disease or clinically significant increased levels of serum amylase or lipase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities | Baseline to Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Change in cardiac parameters R-R interval and ventricular rate measured by electrocardiogram | Baseline to Day 7 |
Countries
United States
Outcome results
None listed