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)

Amyotrophic Lateral Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511029
• Other study ID #: 223HV102
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: November 24, 2014
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: November 2014
• Source: Knopp Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis

Intervention

Drug:
• Dexpramipexole
300 mg - Oral Tablets
• Dexpramipexole
600 mg Oral Tablets
• Dexpramipexole Placebo
Placebo - Oral Tablet
• Moxifloxacin
400 mg - Oral Tablet

Locations

Country	Name	City	State
United States	Research Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Knopp Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Change in ECG measurements		baseline and Day 7	Yes
Secondary	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	Yes
Secondary	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	Yes