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)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01511029
• Date of registration: 09/01/2012
• Prospective Registration: No
• Primary sponsor: Knopp Biosciences
• Public 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)
• Scientific 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
• Date of first enrolment: January 2012
• Target sample size: 68
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01511029
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Drug: Moxifloxacin

Drug: Dexpramipexole Placebo

Drug: Dexpramipexole

Primary Outcome(s)

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(s)

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]

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]

Secondary ID(s)

223HV102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors