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

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 |
- 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 ]
- 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 ]
- Change in ECG measurements [ Time Frame: baseline and Day 7 ]
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
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.

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
United States, Kansas | |
Research Site | |
Overland Park, Kansas, United States |
Responsible Party: | Knopp Biosciences |
ClinicalTrials.gov Identifier: | NCT01511029 |
Other Study ID Numbers: |
223HV102 |
First Posted: | January 18, 2012 Key Record Dates |
Last Update Posted: | November 25, 2014 |
Last Verified: | November 2014 |
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 Pramipexole Anti-Bacterial Agents Anti-Infective Agents |
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