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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01449578 |
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Date of registration:
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22/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dexpramipexole SAD/MAD Study
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Scientific title:
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A Randomized, Blinded, Placebo-Controlled Ascending Dose Study of the Safety and Pharmacokinetics of Dexpramipexole in Healthy Volunteers |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01449578 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must give written informed consent.
- Adult males/females aged 18 to 55 years inclusive and between 19 and 30 kg/m2 body
mass index (BMI), inclusive at screening.
- Subjects who are healthy as determined by prestudy medical history, physical
examination and 12-lead ECG.
- Subjects of childbearing potential must practice effective contraception during the
study and be willing and able to continue contraception for 1 month (females) or 3
months (males) after their last dose of study treatment.
- 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).
- A prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval
>450 ms before study treatment administration) at screening, admission or pre-dose on
Day 1.
- Any clinically important abnormalities in resting ECG that may interfere with the
interpretation of QTc interval changes at screening, admission or pre-dose on Day 1.
- Prior exposure to dexpramipexole.
- Treatment with pramipexole or any dopamine agonist within 1 year.
- Treatment with another investigational drug or approved therapy for investigational
use within 30 days, or 5 half-lives (whichever is longer), or in follow up for any
other drug, biologic, or device study.
- Currently active infection or serious infection (e.g., pneumonia, septicemia) within
the 2 months prior to Day -2 as determined by the Investigator.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive
during the study.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Drug: Dexpramipexole
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Drug: Dexpramipexole Placebo
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Primary Outcome(s)
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Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations and clinical laboratory tests.
[Time Frame: Change from baseline to 11 Days.]
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Secondary Outcome(s)
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Dexpramipexole pharmacokinetics time frame in plasma
[Time Frame: pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours post-dose]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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