Safety Study of Tecadenoson to Treat Atrial Fibrillation

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: Tecadenoson; Drug: Esmolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713401

CVT 4129

Details and patient eligibility

About

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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 5 patient groups

Cohort A

Experimental group

Description:

Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol low dose infusion

Treatment:

Drug: Esmolol

Drug: Tecadenoson

Cohort B

Experimental group

Description:

Period 1: 150 mcg, i.v. bolus. Period 2: 150 mcg, i.v. bolus + esmolol low dose infusion

Treatment:

Drug: Esmolol

Drug: Tecadenoson

Cohort C

Experimental group

Description:

Period 1: 300 mcg, i.v. bolus. Period 2: 300 mcg, i.v. bolus + esmolol low dose infusion

Treatment:

Drug: Esmolol

Drug: Tecadenoson

Cohort D

Experimental group

Description:

Period 1: 75 mcg, i.v. bolus. Period 2: 75 mcg, i.v. bolus + esmolol high dose infusion

Treatment:

Drug: Esmolol

Drug: Tecadenoson

Cohort E

Experimental group

Description:

Period 1: 150 or 300 mcg, i.v. bolus. Period 2: 150 or 300 mcg, i.v. bolus + esmolol high dose infusion

Treatment:

Drug: Esmolol

Drug: Tecadenoson