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

January 9, 2012
July 19, 2012
January 2012
May 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01511029 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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)
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

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
  • Drug: Dexpramipexole
    300 mg - Oral Tablets
  • Drug: Dexpramipexole
    600 mg Oral Tablets
  • Drug: Dexpramipexole Placebo
    Placebo - Oral Tablet
  • Drug: Moxifloxacin
    400 mg - Oral Tablet
  • Experimental: Dexpramipexole
    Interventions:
    • Drug: Dexpramipexole
    • Drug: Dexpramipexole
  • Placebo Comparator: Dexpramipexole (placebo)
    Intervention: Drug: Dexpramipexole Placebo
  • Active Comparator: Moxifloxacin
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01511029
223HV102
No
Biogen Idec Medical Director, Biogen Idec, Inc.
Biogen Idec
Not Provided
Not Provided
Biogen Idec
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP