Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electro… (NCT01511029) | Clinical Trial Compass
CompletedPhase 1
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)
United States68 participantsStarted 2012-01
Plain-language summary
To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
To evaluate whether a single dose of dexpramipexole prolongs the QTC interval as measured by frequent ECG measurements (using Holter monitoring) of individually corrected QT intervals (QTcI)