Back to resultsStudy 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)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dexpramipexole
Dexpramipexole
Dexpramipexole Placebo
Moxifloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis
Eligibility 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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Dexpramipexole
Dexpramipexole (placebo)
Moxifloxacin
Arm Description
Outcomes
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)
Secondary Outcome Measures
Area Under Curve (AUC) of dexpramipexole
Change in ECG measurements
Cmax of dexpramipexole
Tmax of dexpramipexole
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01511029
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Knopp Biosciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexpramipexole
Arm Type
Experimental
Arm Title
Dexpramipexole (placebo)
Arm Type
Placebo Comparator
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexpramipexole
Intervention Description
300 mg - Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Dexpramipexole
Intervention Description
600 mg Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Dexpramipexole Placebo
Intervention Description
Placebo - Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin
Intervention Description
400 mg - Oral Tablet
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Change in ECG measurements
Time Frame
baseline and Day 7
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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