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 (Responsible Party):
Knopp Biosciences Identifier:
First received: January 9, 2012
Last updated: November 24, 2014
Last verified: November 2014
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 Knopp Biosciences:

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.
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Please refer to this study by its identifier: NCT01511029

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Knopp Biosciences
  More Information

Responsible Party: Knopp Biosciences Identifier: NCT01511029     History of Changes
Other Study ID Numbers: 223HV102 
Study First Received: January 9, 2012
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Motor Neuron Disease
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Dyskinesia Agents
Anti-Infective Agents
Antineoplastic Agents
Antiparkinson Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Dopamine Agents
Dopamine Agonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Protective Agents processed this record on May 26, 2016