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.
Information provided by:
Biogen Idec Identifier:
First received: January 9, 2012
Last updated: July 19, 2012
Last verified: July 2012

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

Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: Dexpramipexole
Drug: Dexpramipexole Placebo
Drug: Moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 68
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexpramipexole Drug: Dexpramipexole
300 mg - Oral Tablets
Drug: Dexpramipexole
600 mg Oral Tablets
Placebo Comparator: Dexpramipexole (placebo) Drug: Dexpramipexole Placebo
Placebo - Oral Tablet
Active Comparator: Moxifloxacin Drug: Moxifloxacin
400 mg - Oral Tablet

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01511029

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc. Identifier: NCT01511029     History of Changes
Other Study ID Numbers: 223HV102
Study First Received: January 9, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes
Norgestimate, ethinyl estradiol drug combination
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Anti-Infective Agents
Contraceptives, Oral, Combined
Contraceptives, Oral processed this record on April 17, 2014