A Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Healthy
Interventions
DRUG

Treatment A (domperidone 10 mg)

1 domperidone 10 mg capsule four times a day (q.i.d.) + 1 domperidone placebo capsule q.i.d. on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.

DRUG

Treatment B (domperidone 20 mg)

2 domperidone 10 mg capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.

DRUG

Treatment C (placebo)

2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.

DRUG

Treatment D (moxifloxacin)

2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin 400 mg capsule in the morning of Day 1.

Trial Locations (1)

Unknown

Merksem

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01643889 - A Study to Evaluate the Effects of Domperidone on Cardiac Repolarization in Healthy Volunteers | Biotech Hunter | Biotech Hunter