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)

• Sponsor: Knopp Biosciences (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01511029
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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; 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

• Study Type: Interventional
• 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: Jan 1, 2012
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

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

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) [change from baseline]

Secondary Outcome Measures

1. Area Under Curve (AUC) of dexpramipexole [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 [baseline and Day 7]

3. Cmax of dexpramipexole [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Overland Park	Kansas	United States

Sponsors and Collaborators

• Knopp Biosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Knopp Biosciences
• ClinicalTrials.gov Identifier: NCT01511029
• Other Study ID Numbers: 223HV102
• First Posted: Jan 18, 2012
• Last Update Posted: Nov 25, 2014
• Last Verified: Nov 1, 2014

• Additional relevant MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Moxifloxacin; Pramipexole

Study Results

No Results Posted as of Nov 25, 2014