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)

This study has been completed.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT01511029

First received: January 9, 2012

Last updated: July 19, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 9, 2012
Last Updated Date	July 19, 2012
Start Date ^ICMJE	January 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	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) [ Time Frame: change from baseline ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01511029 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Area Under Curve (AUC) of dexpramipexole [ Time Frame: 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 ] [ Designated as safety issue: Yes ] Change in ECG measurements [ Time Frame: baseline and Day 7 ] [ Designated as safety issue: Yes ] Cmax of dexpramipexole [ Time Frame: 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 ] [ Designated as safety issue: Yes ] Tmax of dexpramipexole [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	A Single-Center, Randomized, Blinded, Placebo- and Active-Controlled Crossover Study to Evaluate the Effect of Dexpramipexole (BIIB050) on the QTc Interval in Healthy Volunteers
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 Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Amyotrophic Lateral Sclerosis
Intervention ^ICMJE	Drug: Dexpramipexole 300 mg - Oral Tablets Drug: Dexpramipexole 600 mg Oral Tablets Drug: Dexpramipexole Placebo Placebo - Oral Tablet Drug: Moxifloxacin 400 mg - Oral Tablet
Study Arm (s)	Experimental: Dexpramipexole Interventions: Drug: Dexpramipexole Drug: Dexpramipexole Placebo Comparator: Dexpramipexole (placebo) Intervention: Drug: Dexpramipexole Placebo Active Comparator: Moxifloxacin Intervention: Drug: Moxifloxacin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	68
Completion Date	May 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01511029
Other Study ID Numbers ^ICMJE	223HV102
Has Data Monitoring Committee	No
Responsible Party	Biogen Idec Medical Director, Biogen Idec, Inc.
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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