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)

Knopp Biosciences

Status and phase: Completed; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Dexpramipexole Placebo; Drug: Moxifloxacin; Drug: Dexpramipexole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01511029

223HV102

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

Dexpramipexole

Experimental group

Treatment:

Drug: Dexpramipexole

Drug: Dexpramipexole

Dexpramipexole (placebo)

Placebo Comparator group

Treatment:

Drug: Dexpramipexole Placebo

Moxifloxacin

Active Comparator group

Treatment:

Drug: Moxifloxacin