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)

NCT01511029 | Completed Phase 1

• 1 other identifier: 223HV102
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

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)

  change from baseline

Secondary Outcomes (4)

• 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

• Change in ECG measurements

  baseline and Day 7

• 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

• 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

Study Arms (3)

Dexpramipexole

EXPERIMENTAL

Drug: Dexpramipexole

Dexpramipexole (placebo)

PLACEBO COMPARATOR

Drug: Dexpramipexole Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

Dexpramipexole DRUG

300 mg - Oral Tablets

Dexpramipexole

Dexpramipexole Placebo DRUG

Placebo - Oral Tablet

Dexpramipexole (placebo)

Moxifloxacin DRUG

400 mg - Oral Tablet

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Knopp Biosciences: lead

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Dexpramipexole; Moxifloxacin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 25, 2014

Record last verified: 2014-11

Locations

US (1)