CiPA Phase 1 ECG Biomarker Validation Study

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 14, 2017

Primary Completion Date

June 26, 2017

Study Completion Date

June 26, 2017

Conditions
Drug-induced QT ProlongationPharmacokineticsPharmacodynamics
Interventions
DRUG

Ranolazine

Ranolazine 1500 mg orally two times per day for 2.5 days

DRUG

Verapamil

Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)

DRUG

Lopinavir / Ritonavir

Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days

DRUG

Chloroquine

Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)

DRUG

Placebo

Placebo (administered orally)

DRUG

Dofetilide and Diltiazem

"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."

Trial Locations (1)

53095

Spaulding Clinical Research, West Bend

All Listed Sponsors
collaborator

Spaulding Clinical Research LLC

OTHER

lead

Food and Drug Administration (FDA)

FED

NCT03070470 - CiPA Phase 1 ECG Biomarker Validation Study | Biotech Hunter | Biotech Hunter