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)

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Dexpramipexole Placebo; Drug: Moxifloxacin; Drug: Dexpramipexole

• Registration Number: NCT01511029
• Lead Sponsor: Knopp Biosciences

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. This thorough QT/QTc study will be conducted to formally evaluate the effect of dexpramipexole on QT prolongation.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-18
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dexpramipexole (placebo)	Dexpramipexole Placebo	-
Moxifloxacin	Moxifloxacin	-
Dexpramipexole	Dexpramipexole	-

Primary Outcome Measures

Name	Time	Method
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)	change from baseline

Secondary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of dexpramipexole	pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period
Change in ECG measurements	baseline and Day 7
Cmax of dexpramipexole	pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period
Tmax of dexpramipexole	pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 23 hours after dosing on Day 1 of each treatment period

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States