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

Study Purpose:

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

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:

Dexpramipexole, Dexpramipexole Placebo, Moxifloxacin



Phase 1

Study Chair(s)/Principal Investigator(s):


Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Research Site

Overland Park, Kansas, United States

Full Study Summary:

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.

Study Sponsor:

Knopp Biosciences

Estimated Enrollment:


Estimated Study Start Date:

12 / 31 / 2011

Estimated Study Completion Date:

05 / 01 / 2012

Posting Last Modified Date:

11 / 25 / 2014

Date Study Added to neals.org:

01 / 18 / 2012

Minimum Age:

18 Years

Maximum Age:

60 Years

Inclusion Criteria:

- Aged 18 to 60 years old inclusive on Day 1.

- Subjects who, in the opinion of the Investigator, are healthy as determined by pre study medical history, physical examination, and 12 lead ECG.

- Male subjects and female subjects of childbearing potential must practice effective contraception (per protocol specifications).

- Normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmHg and a diastolic blood pressure of 50 to 90 mmHg.

Exclusion Criteria:

- History of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, Long QT Syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.

- A prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval >450 ms before study treatment administration.

- Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening, check-in, or pre-dose on Day -1 of the first treatment period.

- Other medically significant illness.

- Clinically significant abnormal laboratory values.

- Pregnant women or women breastfeeding.

Research Site

Overland Park, Kansas
United States