Atrial Fibrillation MedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Product Code: K201 Injection
Pharmaceutical Form: Injection*
INN or Proposed INN: K201
CAS Number: 1038410-88-6
Current Sponsor code: K201
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Sequel Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent 2. Male or female 18 years of age or greater; women of child bearing potential must use adequate contraception: IUD or hormonal contraception (p-pill, implant, transdermal depot patch, vaginal ring or depot injection). 3. Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms). 4. Atrial fibrillation documented by ECG at the start of study drug infusion. 5. Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous exposure to K201 2. Women who are pregnant or breast feeding. (Women of child bearing potential must have a negative pregnancy test prior to randomization.) 3. Systolic blood pressure 38°C (oral or equivalent) 6. QTcF (Fridericia correction) >440 ms 7. QRS interval >140 ms 8. Paced atrial or paced ventricular rhythm on ECG 9. Serum potassium 200 kg 27. Any unrelated illness (e.g. active infection, inflammation, medical condition or laboratory abnormalities) which in the judgment of the investigator would significantly jeopardize patients' clinical status 28. Have received potent CYP2D6 or CYP3A inhibitors within 5 half-lives. Potent CYP2D6 include bupropion, fluoxetine, paroxetine, cinacalcet and quinidine. Potent CYP3A inhibitors include indinavir, nelfinavir, ritonavir, saquinavir, clarithromycin, telithromycin, itraconazole, ketoconazole, vorikonazole, posakonazole, and nefazodone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of 3 escalating doses of intravenous K201 administered for up to 180 minutes on the rate of conversion to sinus rhythm, the changes in AF symptom score and safety parameters such as adverse event reporting, laboratory findings, vital signs and ECG data. To obtain plasma concentration data through 24 hours for K201 and the metabolite M-II for PK analysis;Secondary Objective: See Above;Primary end point(s): The objective of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on the following endpoints: • The proportion of subjects who convert to sinus rhythm for at least 1 minute through 4 hours after start of study drug infusion as documented by 2 sets if ECG data recorded at least 1 minute apart • Proportion of subjects in sinus rhythm at 4 hours from start of study drug • Time to restoration of sinus rhythm will be documented. • Mean change in subject symptom score from baseline to 4 hours after start of study drug infusion • Proportion of subjects with complete absence of symptoms (symptom score of 0) at 4 hours from start of study drug infusion. Additional analyses will examine the changes from baseline and differences between doses for: • Heart rate and the RR, QRS, QT, QTcF, and QTcB intervals • Blood Pressure • AE’s and SAE’s, • Polymorphic ventricular tachycardia and other documented arrhythmias • Clinical laboratory assays | — |
Countries
Denmark
Outcome results
None listed