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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)

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ClinicalTrials.gov Identifier: NCT01511029
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : November 25, 2014
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences

Study Description
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Brief Summary:
To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: Dexpramipexole Drug: Dexpramipexole Placebo Drug: Moxifloxacin Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change in ECG measurements [ Time Frame: baseline and Day 7 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511029


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Knopp Biosciences
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01511029     History of Changes
Other Study ID Numbers: 223HV102
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Pramipexole
Anti-Bacterial Agents
Anti-Infective Agents
 Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antioxidants
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents