Electrophysiological Effects of Potential QT Prolonging Drugs

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

March 21, 2023

Primary Completion Date

June 13, 2023

Study Completion Date

June 13, 2023

Conditions
Drug-induced QT ProlongationPharmacokineticsPharmacodynamics
Interventions
DRUG

Clarithromycin

"Subjects receive the Clarithromycin intervention orally according to the following schedule:~Day 1: 1 Clarithromycin 500 mg immediate release (IR) tablet twice (Clarithromycin 500 mg BID).~Day 2: 2 Clarithromycin 500 mg immediate release (IR) tablets twice (Clarithromycin 1000 mg BID).~Day 3: 2 Clarithromycin 500 mg immediate release (IR) tablets once (Clarithromycin 1000 mg QD)."

DRUG

Pimozide

"Subjects receive the Pimozide intervention orally according to the following schedule:~Days 1-3: Pimozide 6 mg immediate release (IR) once per day."

DRUG

Placebo (Part 1)

Subjects receive matching placebo for treatments.

DRUG

Moxifloxacin

Subjects receive Moxifloxacin 800 mg orally once on day 1.

DRUG

Cobicistat

Subjects receive Cobicistat 450 mg orally once on day 1.

DRUG

Moxifloxacin and Cobicistat

Subjects receive Moxifloxacin 800 mg and Cobicistat 450 mg orally once on day 1.

DRUG

Placebo (Part 2)

Subjects receive matching placebo for treatments.

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