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)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01511029
First received: January 9, 2012
Last updated: July 19, 2012
Last verified: July 2012
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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
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Drug Information available for:
Pramipexole dihydrochloride
Pramipexole
Moxifloxacin
Moxifloxacin hydrochloride
U.S. FDA Resources
Further study details as provided by Biogen Idec:
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 |
| 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 More Information
No publications provided
| Responsible Party: | Biogen Idec Medical Director, Biogen Idec, Inc. |
| ClinicalTrials.gov Identifier: | NCT01511029 History of Changes |
| Other Study ID Numbers: | 223HV102 |
| Study First Received: | January 9, 2012 |
| Last Updated: | July 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Pramipexol Moxifloxacin Norgestimate, ethinyl estradiol drug combination |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agonists Dopamine Agents Neurotransmitter Agents Anti-Infective Agents Contraceptives, Oral, Combined Contraceptives, Oral |
ClinicalTrials.gov processed this record on June 17, 2013