Study to Evaluate the Pharmacokinetics and the Safety of M518101 in Plaque Psoriasis Patients
NCT ID: NCT01844973
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2013-04-30
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Vehicle
Vehicle
Proper quantity twice a day
M518101
M518101
Proper quantity twice a day
Interventions
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M518101
Proper quantity twice a day
Vehicle
Proper quantity twice a day
Eligibility Criteria
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Inclusion Criteria
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have ≥20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Exclusion Criteria
* BMI \> 32.0 kg/m2
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.
* Who have taken any durg with known effects on calcium metabolism within 30days of randomization
* Who have been treated with any drug with a known risk of QT prolongation within 30days of randomization.
18 Years
ALL
No
Sponsors
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Maruho North America Inc.
INDUSTRY
Responsible Party
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Locations
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Orenge County Research Center
Tustin, California, United States
Countries
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Other Identifiers
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M518101-US05
Identifier Type: -
Identifier Source: org_study_id