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CompletedNCT01511029Updated Nov 25, 2014

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)

A Phase 1 interventional study of Dexpramipexole and Dexpramipexole in Amyotrophic Lateral Sclerosis, sponsored by Knopp Biosciences. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-25.

Sponsored by Knopp Biosciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.

Read the 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.

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 68 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Knopp Biosciences is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    Dexpramipexole

    Drug: Dexpramipexole

  • Placebo comparator
    Dexpramipexole (placebo)

    Drug: Dexpramipexole Placebo

  • Active comparator
    Moxifloxacin

    Drug: Moxifloxacin

Interventions

  • DrugDexpramipexole

    300 mg - Oral Tablets

  • DrugDexpramipexole

    600 mg Oral Tablets

  • DrugDexpramipexole Placebo

    Placebo - Oral Tablet

  • DrugMoxifloxacin

    400 mg - Oral Tablet

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Research Site
    Overland Park, Kansas, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01511029
Lead sponsor
Knopp Biosciences
Responsible party
Sponsor
First posted
Jan 18, 2012
Start date
Jan 2012
Primary completion
May 2012
Completion
May 2012
Last update
Nov 25, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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