NCT01511029

Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)

A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.

Detailed description

This is a Phase I, single-center, blinded (with respect to dexpramipexole administration), randomized, placebo- and active-controlled, 4-period crossover study in approximately 68 healthy volunteers. This thorough QT/QTc study will be conducted to formally evaluate the effect of dexpramipexole on QT prolongation.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dexpramipexole	300 mg - Oral Tablets
DRUG	Dexpramipexole	600 mg Oral Tablets
DRUG	Dexpramipexole Placebo	Placebo - Oral Tablet
DRUG	Moxifloxacin	400 mg - Oral Tablet

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2012-01-18
• Last updated: 2014-11-25

Locations

1 site across 1 country: United States