Atrial Fibrillation
Conditions
Brief summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Interventions
DRUGK201 Injection
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
Sponsors
Sequel Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptomatic atrial fibrillation * Atrial fibrillation documented by ECG * Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.
Exclusion criteria
* Systolic blood pressure \<100 mmHg * Heart rate \<50 bpm * Temperature \>38°C * QT or QTcB \>440 ms * QRS \>140 ms * Paced atrial or ventricular rhythm on ECG * Serum potassium \<3.5 meq/L * History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization * History of amiodarone in last 6 months. * Clinical evidence of acute coronary syndrome * Acute pulmonary edema or embolism * Hyperthyroidism * Acute pericarditis * History of failed electrical cardioversion at any time * History of torsades des pointes * History of familial long QT interval syndrome * History of ventricular tachycardia requiring drug or device therapy * History of NYHA Heart Failure Class 3 or 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restoration of sinus rhythm | 24hrs |
Countries
Israel, Russia
Outcome results
None listed