Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Drug-induced QT ProlongationPharmacokineticsPharmacodynamics
Interventions
DRUG

Dofetilide

"* 8 am: Placebo~* 12 pm (noon): 250 µg~* 5:30 pm: 250 µg"

DRUG

Mexiletine

"* 8 am: weight x 4 mg/kg~* 12 pm (noon): Same as at 8 am~* 5:30 pm: Same as at 8 am"

DRUG

Lidocaine

"* 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes~* 2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes~* 7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"

DRUG

Moxifloxacin

"* 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)~* 2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~* 7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)"

DRUG

Diltiazem

• 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes

DRUG

Placebo

Placebo (#2 Gelcap or IV saline)

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT02308748 - Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block | Biotech Hunter | Biotech Hunter