Table 2. Select Clinical Trials in Healthy Volunteers.
Study N Antiemetic treatments Electrocardiogram assessments Electrocardiographic effects

Hunt 1995

Randomized, double-blind, placebo-controlled dose-ranging (single-dose)

 80

D:0.6-, 0.8-, 1-, 1.25-, 1.5-, 1.75-, 2-, 2.25-,
2.5-, 2.75-, 3-, 3.5-, 4-; 4.5-, and 5-mg/kg IV over 10 min

Placebo

 

 Prior to antiemetic therapy (baseline), at 1-2 h after antiemetic, and at end of evaluation period
(48 or 72 h)

1. Reversible changes in PR and QRS complex durations.

2. Patients were asymptomatic.

3. None of the QTc interval measurements were > 420 msec, even at the highest dose.
Benedict 1996

Randomized,
placebo-controlled,
single-blind,
5-way crossover
 30

D:1.2-, 1.8-, or 2.4-mg/kg IV over 15 min

O: 32 mg IV over 15 minutes

Placebo

Prior to antiemetic therapy (baseline), and at 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 h after antiemetic

1. Acute, transient, and asymptomatic ECG interval changes with D and O.

2. None of the QTc interval measurements were >420 msec, even at the highest dose.

3. Increases in QT and QTc intervals were statistically significant, but not considered clinically significant

4. All changes returned to baseline by 8 h.
Boike 1997

Randomized, double-blind,
double-dummy,
4-period,
crossover
 13 G: 10 mcg/kg IV over either 30 sec or 5 min

O: 32 mg IV

Placebo 		Prior to antiemetic therapy, after infusion, and at intervals up to 24 hours after the third injection

1. O,G, and placebo all prolonged QTc interval without demonstrable clinical effects, although QTc interval was significantly prolonged with O versus G or placebo.

2. No significant differences between O, G, or placebo in other ECG intervals, although all were slightly prolonged.

3. No prolongation of any ECG interval was clinically meaningful.
Upward 1990

Single-blind,
placebo-
controlled,
dose-escalation
crossover

 8 G: 2.5-300 mcg/kg IV over 30 min
G: 40-160 mcg/kg IV over 3 min

Placebo 		Prior to antiemetic therapy (baseline) and at end of infusion

1. Only results for the 300 mcg/kg dose were reported.

2. No clinically significant changes in pulse, blood pressure, or ECG intervals during or after antiemetic admininstration.

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