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) - Full Text View

Purpose

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

Condition	Intervention	Phase
Amyotrophic Lateral Sclerosis	Drug: Dexpramipexole Drug: Dexpramipexole Placebo Drug: Moxifloxacin	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

Drug Information available for: Pramipexole dihydrochloride Pramipexole Moxifloxacin Moxifloxacin hydrochloride

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Knopp Biosciences:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
Change in ECG measurements [ Time Frame: baseline and Day 7 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]


Enrollment:	68
Study Start Date:	January 2012
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511029

Locations


United States, Kansas
Research Site
Overland Park, Kansas, United States

Sponsors and Collaborators

Knopp Biosciences

More Information


Responsible Party:	Knopp Biosciences
ClinicalTrials.gov Identifier:	NCT01511029 History of Changes
Other Study ID Numbers:	223HV102
Study First Received:	January 9, 2012
Last Updated:	November 24, 2014
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Motor Neuron Disease Amyotrophic Lateral Sclerosis Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Pramipexole Anti-Bacterial Agents Anti-Infective Agents	Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Antioxidants Protective Agents Antiparkinson Agents Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on September 23, 2016