Status:
COMPLETED
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)
Lead Sponsor:
Knopp Biosciences
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT01511029
Start Date
January 1 2012
End Date
May 1 2012
Last Update
November 25 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Overland Park, Kansas, United States