Study Purpose:To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.
Amyotrophic Lateral Sclerosis
Type of Intervention:
Dexpramipexole, Dexpramipexole Placebo, Moxifloxacin
Study Chair(s)/Principal Investigator(s):
Coordinating Center Contact Information
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.
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
60 YearsInclusion 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.
- 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.
Overland Park, Kansas